High Blood Pressure clinical trials at University of California Health
73 in progress, 34 open to eligible people
Sotatercept for PAH Treatment (MK-7962-004/A011-12)
open to eligible people ages 18 years and up
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.
at UC Davis UC Irvine UCLA UCSD UCSF
Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients
open to eligible people ages 18 years and up
This is a randomized single-blind feasibility trial to test the utilization of home blood pressure devices to improve the clinical management of decompensated cirrhosis patients.
at UCSF
Pivotal Study to Evaluate the Efficacy of Lorundrostat in Subjects With Uncontrolled Hypertension on a Standardized Antihypertensive Medication Regimen
open to eligible people ages 18 years and up
a Phase 2 trial to evaluate the blood pressure-lowering effect of lorundrostat (an aldosterone synthase inhibitor), administered on a background of a standardized anti-hypertensive (AHT) medication regimen, in subjects with uncontrolled and/or treatment-resistant hypertension.
at UC Irvine UCSD
Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
open to eligible people ages 18 years and up
The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in participants with pulmonary arterial hypertension (PAH).
at UC Davis UCSF
Ralinepag to Improve Treatment Outcomes in PAH Patients
open to eligible people ages 18 years and up
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
at UC Davis UC Irvine UCLA UCSD
Sotatercept for the Treatment of Cpc-PH Due to HFpEF (MK-7962-007/A011-16)
open to eligible people ages 18-85
This is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. The objective of this study is to evaluate the efficacy, safety and tolerability of sotatercept versus placebo in adults with Cpc-PH due to HFpEF. Efficacy is measured by change from baseline in pulmonary vascular resistance (PVR, primary endpoint) and 6-minute walk distance (6MWD, key secondary endpoint).
at UC Irvine UCLA
Acupuncture Therapy and Hypertension
open to eligible people ages 50-75
Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will not be on hypertensive medications. The course last for 8 weeks and the frequency is once a week.
at UC Irvine
Electro-Acupuncture on Blood Pressure
open to eligible people ages 39-85
Based on previous published research in animals and human, the investigators hypothesize that electroacupuncture (EA) will have a positive effect on hypertension.
at UC Irvine
Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study
“Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”
open to eligible people ages 18-80
The objectives of this study are to evaluate the safety of RT234 and the effects of RT234 on exercise capacity as assessed by Cardiopulmonary Exercise Testing (CPET) and six minute walk testing (6MWT) as well as exertional symptoms in patients with pulmonary arterial hypertension (PAH).
at UC Davis UCLA UCSF
Seralutinib in Adult Subjects With PAH (PROSERA)
open to eligible people ages 18-75
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.
at UC Davis UC Irvine
Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
open to eligible people ages 18 years and up
Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.
at UCSF
Hypertension in Young Adults Trial
open to eligible people ages 18-40
This is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.
at UCSF
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
open to eligible people ages 18-85
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
at UC Davis UC Irvine UCSF
Metformin for Pulmonary Hypertension HFpEF
open to eligible people ages 18 years and up
The main objective of this study is to determine the clinical efficacy of metformin versus placebo and the therapeutic response with regards to functional capacity and hemodynamics in PH-HFpEF.
at UCSF
Mi Propio Camino Intervention RCT for Blood Pressure Medication Adherence
open to eligible people ages 18 years and up
The purpose of this study is to compare the effect of two educational interventions on adherence to blood pressure medications among adults with uncontrolled hypertension.
at UC Irvine
Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension
open to eligible people ages 3 months to 18 years
The investigators' central hypothesis is that early combination therapy with two PAH-specific oral therapies that have been shown to be well tolerated in the pediatric population, sildenafil and bosentan, will result in better World Health Organization (WHO) functional class at 12 months after initiation of PAH treatment than therapy with sildenafil alone.
at UCSF
NEPH-ROSIS (NEPHrology in CirRhOSIS) Pilot Trial: A Trial to Treat Acute Kidney Injury Among Hospitalized Cirrhosis Patients
open to eligible people ages 18 years and up
The goal of this pilot, randomized, single-blind clinical trial is to estimate the effect size of a high and low mean arterial pressure (MAP)-target algorithm among cirrhosis patients hospitalized with acute kidney injury. The main aims to answer are: • Does an algorithm that has low (<80 mmHg) and high (≥80) MAP-targets lead to significant differences in mean arterial pressure? • Are there any serious adverse events (e.g., ischemia) in a high blood pressure algorithm as compared to a low blood pressure algorithm? • Are there any differences in the incidence of AKI reversal in the high v. low MAP-target groups? Participants will be: 1) Randomized to a clinical algorithm that will either target a low (<80 mmHg) or high (≥80 mmHg) MAP. 2) Depending on their group, investigators will titrate commonly used medications to a specific MAP target. Researchers will compare the high and low MAP-target groups to see if these algorithms lead to significant changes in MAP, if they have any impact on AKI reversal, and if there are any adverse events in the high MAP-target group.
at UCSF
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
open to eligible people ages 18-80
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
at UC Davis UCLA
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
open to eligible people ages 18-80
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).
at UCLA
Clarifying the Optimal Application of SLT Therapy Trial
“Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!”
open to eligible people ages 18 years and up
The goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.
at UC Davis UCLA UCSF
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)
open to eligible people ages 18 years and up
The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.
at UCSF
Secondhand Tobacco Smoke and Cardiovascular Disease
open to eligible people ages 40 years and up
This is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke.
at UCSF
Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
open to eligible people ages 18 years and up
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.
at UC Davis UC Irvine UCLA UCSD
Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
open to eligible people ages 1-17
The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to <18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.
at UCLA UCSF
Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
open to eligible people ages 18 years and up
This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.
at UCLA UCSD
ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
open to eligible people ages 18 years and up
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.
at UCSF
Dry Powder Inhaled Treprostinil in PH
open to eligible people ages 18-80
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 & 3 PH.
at UC Davis UCLA UCSF
Chronic Thromboembolic Disease Registry
open to eligible people ages 18 years and up
The goal of this patient registry is to learn about the natural history in patients with chronic thromboembolic disease (CTD) and/or chronic thromboembolic pulmonary hypertension (CTEPH). The main question[s] it aims to answer are: - Long-term outcome after various types of treatment, including medication, balloon pulmonary angioplasty, and pulmonary endarterectomy - Effect of treatment on patient's quality of life and exercise tolerance Participants will be followed longitudinally to assess their health outcomes and quality of life via chart review and health quality surveys.
at UCSF
Multi-Omics for Maternal Health After Preeclampsia
open to eligible females ages 18-50
To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.
at UCSD
Novel Index (PIMR) in PAH
open to eligible people ages 18 years and up
The chief regulator of resistance in pulmonary arterial hypertension (PAH) is the small arteries. In the heart, the invasive measurement of the resistance of the small arteries has been shownto be safe, easy, reliable, and prognostic. This study is intended to translate prior work in heart arteries to the PAH space and invasively measure the resistance of the small arteries of the lung (pulmonary index of microcirculatory resistance [PIMR]) and the coronary artery supplying the right ventricle (acute marginal of the RCA; RV-IMR). Importantly, these measurements will be made during standard of care cardiac catheterizations (right heart catheterization [RHC] +/- left heart catheterization). The correlation between these new indices and the standard ones measured during RHC typically used to determine the severity of pulmonary hypertension will be analyzed. In addition, among newly diagnosed patients, the study will evaluate how these indices change 6 months after starting treatment. Finally, the association of these indices with clinical outcomes at 1 year will be assessed. The findings from this study may deliver an immediate impact to patient care by identifying a new metric to help better identify those who may benefit from a more intensive, personalized treatment regimen.
at UCLA
Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry
open to eligible people ages up to 21 years
Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.
at UCSF
Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
open to eligible people ages 0-20
The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.
at UCLA
Pulmonary Hypertension Association Registry
open to eligible people ages 0 years and up
The PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S. PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes. PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care.
at UC Davis UCSF
PV Loop and Pulmonary Hypertension
open to eligible people ages 1-21
The right ventricular (RV) systolic function is a key determinant of outcome in patients with pulmonary hypertension and elevated pulmonary vascular resistance. As the pulmonary artery pressure and vascular resistance increase (i.e. RV afterload) in these patients, so does the right ventricular contractility in an attempt to maintain cardiac output. This is response of a ventricle to its afterload is termed ventriculo-arterial (VA) coupling. However, there is a limit to this increase in contractility after which VA uncoupling occurs ultimately leading to decrease cardiac output and right ventricular failure. The accepted gold standard for measurement of VA coupling is the ratio of the end systolic ventricular elastance (Ees) to the end systolic arterial elastance (Ea) measured invasively via high fidelity conductance catheters during cardiac catheterization. In this study, the aim is to devise a non-invasive scoring system that can identify VA uncoupling in patients with elevated pulmonary vascular resistance using echocardiography, cardiac MRI, cardiopulmonary exercise testing and brain natriuretic peptide levels. The hypothesis is that a group of morphologic and functional variables obtained noninvasively can differentiate an RV with VA coupling from that with VA uncoupling.
at UCSF
Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Sorry, accepting new patients by invitation only
Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
at UC Davis UC Irvine UCLA UCSD
Selexipag as Add-On Treatment to Standard of Care in Children With Pulmonary Arterial Hypertension
Sorry, in progress, not accepting new patients
The purpose of this study is to evaluate whether the addition of selexipag to standard of care treatment delays disease progression in children with Pulmonary Arterial Hypertension (PAH) in comparison to placebo.
at UCLA UCSF
Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)
Sorry, in progress, not accepting new patients
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.
at UC Irvine UCLA UCSD UCSF
Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
Sorry, in progress, not accepting new patients
This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).
at UCLA UCSF
COHERE - COntextualized Care in cHcs' Electronic Health REcords
Sorry, in progress, not accepting new patients
This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.
at UCSF
Comparing Ascites Relief In Two Standard Treatments: Large Volume Paracentesis Vs. Early Tips Using Viatorr Controlled Expansion Stents
Sorry, in progress, not accepting new patients
For this study, the investigators will be collecting data based on patients' random selection to two different approved standard of care treatments for ascites: Subjects will get randomized into either Group A: Large Volume Paracentesis (LVP) with albumin infusion, or Group B: an early transjugular intrahepatic portosystemic shunt (TIPS) procedure.
at UCLA
Comparing Hypertension Remote Monitoring Evaluation Redesign
Sorry, accepting new patients by invitation only
The goal of this clinical trial is to compare the effectiveness of evidence-based, adapted, and tailored, patient-focused and clinic-focused strategies to improve blood pressure (BP) control in English- and Spanish-speaking patients with hypertension (HTN).
at UCSF
Dietary Intervention to Improve Kidney Transplant Outcomes
Sorry, in progress, not accepting new patients
Randomized controlled trial of a curriculum intervention teaching patients to eat a whole-food plant-based dietary pattern versus standard of care in kidney transplant recipients within the first few months of transplant
at UC Davis
Dietary Sodium Intake and Blood Pressure in Living Kidney Donors
Sorry, currently not accepting new patients, but might later
This is a pilot study to determine the feasibility of the study design and examine the main outcome whether low dietary sodium intake is superior to high dietary sodium intake in controlling blood pressure to be within the normotensive range in living kidney donors.
at UC Irvine
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
Sorry, not yet accepting patients
HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications
at UC Irvine
Treatment of Pre-induction Hypertension on Hemodynamic Stability During Induction of General Anesthesia
Sorry, not yet accepting patients
The purpose of this study is to determine if treatment of pre-induction hypertension with an intravenous short acting calcium channel antagonist will (1) reduce the magnitude and duration of blood pressure excursions outside of a pre-established normal range and (2) decrease the requirement for vasoactive medications during the period from induction of anesthesia until just prior to surgical incision.
at UCSD
Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL
Sorry, not yet accepting patients
The overall goal of this large, pragmatic, comparative effectiveness trial is to test the hypothesis that among at-risk individuals, 162 mg/day aspirin is superior to 81 mg/day in preventing Hypertensive disorders of pregnancy (HDP), and that there are multiple factors associated with adherence with aspirin therapy that will be important to identify to enable optimal implementation of study findings and population-level benefits.
at UCSF
Blood Pressure on Cognition and Cerebral Hemodynamics in PD
Sorry, not yet accepting patients
The goal of clinical trial is to learn about how blood pressure fluctuations affect cognitive performance (thinking abilities) and brain blood flow in persons with Parkinson's disease with and without orthostatic hypotension (low blood pressure when standing). The main questions it aims to answer are: - Is there a certain level of blood pressure that correlates with change in cognitive performance while upright? - Is there a certain level of change in brain blood flow that correlates with change in cognitive performance when upright? - How does cognitive performance differ between persons with Parkinson's disease that have orthostatic hypotension and those without orthostatic hypotension? - How does cognitive performance differ between the supine (laying down) and upright positions? - How do blood pressure and brain blood predict changes in cognitive performance over two years? Participants in this study will undergo the following procedures: - Complete a screening visit with questionnaires, medical history, physical exam, and head-up tilt-table test. - Attend one baseline study visit, during which they will undergo a battery of computerized cognitive tests repeated twice: once while laying down and once while upright on a tilt table. Simultaneously, during the experiments we will measure blood pressure using a wrist-worn device and inflatable arm cuff and will measure brain blood flow using functional near-infrared spectroscopy (fNIRS), a non-invasive device that uses light sensors to detect changes in brain blood flow. - Attend one two-year follow-up visit, during which they will repeat a battery of computerized cognitive tests repeated twice: once while laying down and once while upright on a tilt table. During this visit, like before, we will measure blood pressure using a wrist-worn device and inflatable arm cuff and will measure brain blood flow using functional near-infrared spectroscopy (fNIRS). Researchers will compare participants with Parkinson's disease with and without orthostatic hypotension in the laying down and upright positions to see if there are changes in thinking abilities between these groups.
at UCSD
Human Sodium Balance Study
Sorry, in progress, not accepting new patients
The overall objective of this study is to examine how dietary sodium is used by the body. In a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. This has implications for how investigators interpret studies that use urine biomarkers of sodium. Study findings about tissue sodium storage also have implications for managing hypertension and related conditions.
at UCSD
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR
Sorry, accepting new patients by invitation only
This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.
at UCSD
Mobile Health Intervention to Improve Exercise in Pediatric PH
Sorry, not yet accepting patients
Children and adults with pulmonary arterial hypertension (PAH) have severely reduced daily activity compared to healthy populations. In adults, investigators recently demonstrated that lower baseline daily step counts associated with increased risk of hospitalization and worsening WHO functional class; similarly, reduced step counts associate with hospitalization in children with PAH. This application builds on our recently completed NIH-funded pilot mobile health (mHealth) trial in adult patients with PAH which demonstrated the ability to remotely increase step counts. The investigators now aim to: (1) adapt our mHealth intervention to the developmental needs and interests of adolescents; and, (2) determine if our intervention increases step counts in adolescents, providing the foundation for a larger trial to assess the impact on quality of life and clinical outcomes.
at UCSF
Multi-ethnic Multi-level Strategies and Behavioral Economics to Eliminate Hypertension Disparities in Los Angeles County
Sorry, in progress, not accepting new patients
The goal of the study is to promote equitable hypertension (HTN) management across the diverse patient population found in Los Angeles County Department of Health Services (LAC DHS) clinics. To achieve this goal, the study team will conduct provider- and patient-focused outreach strategies to understand how to best support adoption of blood pressure management practices already available within LAC DHS. LAC DHS clinics will be randomly assigned to one of three study conditions: 1) provider-focused outreach, 2) patient-focused outreach, and 3) usual outreach. The study will occur across 3 years with patient- and provider-focused outreach occurring in Year 1 and 2. In Year 3, study initiated patient- and provider-focused outreach will stop, and clinic use of patient- and provider-focused outreach practices will be observed by the study team. Provider-focused outreach includes increasing cultural awareness of factors that hinder and support blood pressure control, increasing access to blood pressure medications, and providing blood pressure management education. Patient-focused outreach includes using culturally sensitive educational materials and reminders to improve patient understanding of blood pressure, education on how to manage the condition, and increasing awareness of available blood pressure management resources. Clinics assigned to the usual outreach condition will operate as per usual in Year 1 but will receive patient- and provider-focused outreach in Year 2.
at UCLA
Non-Invasive Measurement of Cardiac Output and Stroke Volume in PAH/CTEPH
Sorry, accepting new patients by invitation only
Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are severe clinical conditions that, despite advances in therapeutics over the past 20 years, lead to serious morbidity and mortality. Guidelines on the diagnosis and treatment of pulmonary hypertension (PH) recommend the use of a multiparametric risk stratification tool to determine severity of disease, which should guide initial therapy and therapy modulation. This multiparametric risk stratification schema includes objective assessment of exercise capacity, right ventricular function and hemodynamic parameters in order to classify patients into severity categories. Cardiac index (CI) and right atrial pressure (RAP), measured via right heart catheterization (RHC), are the hemodynamic parameters used in risk assessment of PH. Arguably, stroke volume index (SVI) is the most important hemodynamic parameter for assessment of PH severity and there is currently no validated method for noninvasive measurement of cardiac output (CO), CI or SVI. Currently, a major obstacle in the field is that hemodynamic measurements are not obtained on a regular basis in the risk assessment and therapy modulation of patients with PAH and CTEPH. If a noninvasive method of hemodynamic measurement could be correlated with other objective measurements of risk assessment, it could become an invaluable tool in therapy initiation and modulation in the ambulatory setting. This is a single center study to evaluate the use of non-invasive measurement of CO and stroke volume to assess risk and response to treatment in patients with PAH and non- operable CTEPH. We anticipate to enroll a total of 100 subjects at Ronald Reagan UCLA Medical Center. A maximum of 10 hour in total for the study including the consent process, pre-procedure care, RHC procedure, and follow up visit. The initial visit will be approximately 4 hours with the RHC procedure itself will only be 20 minutes. Each follow up visit will be 1.5 hour. Patients with known or suspected PAH or CTEPH will undergo a RHC as part of his or her standard of care. Three techniques of CO measurement will be performed sequentially at the time of the RHC. The device that will be used is the Edwards ClearSight system and EV1000 clinical platform, a device that measures NIBP. Patients will be followed over the period of 1 year every 3 months to obtain serial measurements for six-minute walk distance (6MWD), World Health Organization (WHO)/New York Heart Association Functional Class (FC), B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP (NT-proBNP), and non-invasive hemodynamic measurements. Additional visits will be scheduled to obtain the serial measurements one month prior and one month following if a patient is initiating or changing PH-specific therapy. As this is a study looking at the feasibility of non-invasive measurement of cardiac output and stroke volume for risk assessment and response to therapy in pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH), study personnel performing the study procedures will not be blinded to the clinical diagnosis and the management of the subject.
at UCLA
Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects with Hypertension
Sorry, accepting new patients by invitation only
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
at UCSD
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
Sorry, in progress, not accepting new patients
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
at UCLA
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Sorry, currently not accepting new patients, but might later
The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers. Suboptimal control of blood pressure is known to be common in patients with the advanced stages of CKD, and may contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and mortality. This proposal is a pilot randomized controlled trial designed to test whether intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.
at UCSF
Reducing Blood Pressure in Patients With High Cardiovascular Risk in the Safety-Net
Sorry, not currently recruiting here
BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services public healthcare system. The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are: - Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care? - Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?
at UC Irvine UCLA
Remote Monitoring for Equity in Advancing Control of Hypertension
Sorry, accepting new patients by invitation only
The goal of this study is to support patients with hypertension self-management using both home blood pressure monitors and digital messaging programs. The investigators will first engage patients with technology training to use home monitors, online portal websites to view their medical record information online, and texting and mobile phone applications. Then investigators will assess the effectiveness of home blood pressure monitors and enhanced patient-clinician digital communication on blood pressure control during a 12-month intervention.
at UCSF
Skills-Based Educational Strategies for Reduction of Vascular Events in Orange County
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The Skills-Based Educational strategies for Reduction of Vascular Events in Orange County, CA (SERVE OC) study aims to evaluate the efficacy of a culturally tailored, skills-based, cardiovascular health (CVH) intervention amongst a cohort of Latinx and Vietnamese families in Santa Ana, CA. The SERVE OC intervention was adapted from our previous work, the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) intervention, for the primordial prevention of hypertension (HTN) and other risk factors for cardiovascular disease (CVD). (The DESERVE study was conducted at New York University under their IRB). The intervention will be delivered by community health workers (CHWs) and will focus on: 1) optimizing risk perception, 2) enhancing provider-family communication, and 3) identifying challenges to CVH. Participants will receive multi-lingual materials and access to an app/web portal to identify healthy goals and strategies around modifiable risk factors for CVH, Life's Essential 8. SERVE OC will follow participants for 36-months to examine changes in CVH using Life's Simple 7 (LS7): smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure (BP) scores and changes in systolic blood pressure (SBP) among adult participants versus enhanced standard intervention (ESI). Remote blood pressure (BP) monitoring will also be used to assess BP over time. CHWs will engage families in identifying barriers to CVH and solutions to share with community stakeholders. Using this community-based research (CBPR) approach the investigators hope to improve health equity within the community through enhanced social capital, empowerment, and advocacy capacity. This study is part of a multi-center projected coordinated by the UCLA-UCI Center for Eliminating Cardio-Metabolic Disparities in Multi-Ethnic Populations (UC END-DISPARITIES), aimed at improving CVH among underserved populations in Los Angeles and Orange County.
at UC Irvine
Preductal Oxygen Saturation Target in Term and Late Preterm Neonates With Hypoxemic Respiratory Failure or Pulmonary Hypertension
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The purpose of this research is to evaluate two oxygen saturation goals for newborns with pulmonary hypertension. Participation in this research will involve random assignment to one of two oxygen saturation goals, review of the medical record and targeted echocardiograms.
at UC Davis
TReatment Of Pulmonary HYpertension 1-US Study
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The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.
at UCSD
TReatment of Pulmonary Hypertension Group II Study
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The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.
at UCSD UCSF
UCSF BP Activate Letter Study
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The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters and no intervention, at shortening time to appointment, time to visit, time to medication change, and time to achievement of BP goal.
at UCSF
University of California Health Remote (Home) Monitoring Evaluation
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This study sets out to evaluate a University of California-wide (Davis, San Francisco, and Los Angeles) quality improvement initiative to increase remote (home) blood pressure monitoring and improve blood pressure control for persons with hypertension. Participants at each site will be randomized to one of two types of remote monitoring: integrated versus manual. Participants using the integrated monitoring will have their home blood pressure readings sent directly to their participating health systems. Participants using the manual monitoring will record their own blood pressures and report them to their health care system as per usual care.
at UC Davis UCLA UCSF
Learn About How Well Riociguat Works, How Safe it is and How it is Used Under Real World Conditions in Patients in the United States Who Are Receiving Riociguat for High Blood Pressure in the Arteries That Carry Blood From the Heart to the Lungs (Pulmonary Arterial Hypertension, PAH)
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Pulmonary arterial hypertension (PAH) is a type of high blood pressure in the arteries that carry blood from the heart to the lungs. PAH occurs when the openings in the blood vessels of the lungs get smaller and smaller. These smaller openings can be caused by the following: - The walls of the arteries tightening - The walls of the arteries becoming stiff and narrow from an overgrowth of cells The increased pressure in the pulmonary arteries strains the right side of the heart and it begins to fail, causing difficulty breathing and other symptoms. As PAH progresses, symptoms get worse. There is no cure for PAH, but several medications like endothelin receptor antagonists (ERAs), prostacyclin analogues (PCAs) and riociguat, a soluable guanylate cyclase stimulator, are available to help slow the progression of changes in the pulmonary arteries and help reduce symptoms. Riociguat can be taken together with ERAs and PCAs. In this study, the researchers want to learn about how well riociguat works, how safe it is when patients take it in 1 of these ways: - alone - with ERA - with PCA - with ERA and PCA The dosage for each patient will be decided by their doctor. The researchers will review information collected from the patients who have decided with their doctor to start riociguat treatment for their PAH. The study will include about 500 patients in the United States who are at least 18 years old. All of the patients will have either just started taking riociguat or will have been taking it for less than 3 months No investigational products will be administered in this study. Patients will be treated with the Standard of Care (SOC) for PAH. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for PAH. There will be no study-mandated visits or treatments. The patients will be in the study for up to 2 years. During this time, they will visit their doctor every 3 to 6 months as part of the Standard of Care. At these visits, the patients will answer questions about their PAH symptoms and whether they have any medical problems. They will also do exercise tests to see how well they are able to breathe and how tired they get while exercising. The doctors will perform other usual examinations which are part of the Standard of Care such as echocardiograms (images of the heart to show how the heart is working) and a right heart catheters (to measure the pressures in the heart) and will take the usual blood and urine samples.
at UC Davis UC Irvine UCSD UCSF
ADAPT - A Patient Registry of the Real-world Use of Orenitram®
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This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation
at UCLA UCSF
Utility of Submaximal CPET in Treatment Management of PAH
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Pulmonary hypertension (PH) is associated with worsening breathlessness and exercise capacity, right-heart failure, and adverse outcomes including increased mortality. Moreover, PH disease progression can be rapid; pharmaceutical intervention in early-stage Pulmonary Hypertension (PH) can improve symptoms and functional capacity, and delayed diagnosis and treatment of Pulmonary Hypertension (PH) likely reduces survival.
at UCLA
Cardiovascular Health Study (CHS)
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To determine the extent to which known risk factors predict coronary heart disease and stroke in the elderly, to assess the precipitants of coronary heart disease and stroke in the elderly, and to identify the predictors of mortality and functional impairments in clinical coronary disease or stroke.
at UC Davis
Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs
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The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the LUNGguard system, as well as retrospective standard of care patients
at UCSF
Human/Machine Interface: What the HeartMate 3 ® Device Tells Us About the Future
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Durable left ventricular assist devices (dLVAD) have been increasingly utilized since the mid to late 1990s, with an uptick of utility starting in 2010 following expanded indications for therapy to not only include a bridge to transplantation strategy, but also for those individuals who suffer from advanced heart failure (HF) and do not qualify for cardiac transplantation. Despite the decreasing size of the newest generation devices leading to a lessened occurrence of adverse events, bleeding and infection still remain a concern for clinicians, as well as a general lack of predictability towards adverse events in individuals with a dLVAD in place. There is a lack of description in the literature currently, regarding the interface between what the pump data provides and what is seen in clinical practice. There also is little known about the effects of what is provided in the pump data, in correlation to quality-of-life following dLVAD implantation. Therefore, the purpose of this study is to prospectively analyze normal and abnormal pump data through pump operations such as suction events, low flow alarms as well as other adventitious alarms, PI events and power cable disconnects greater than 20 seconds, from the HeartMate 3 ® dLVAD in order to clinically correlate this data to quality of life, frailty and other various medical conditions and adverse events as defined by the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs). This will be achieved through two aims: 1) Evaluate the effectiveness of dLVAD pump operations data on clinical practice application (quality of life, frailty and various medical conditions, and adverse events such as GIB, RHF, infection, hypertension, arrhythmias and stroke); and 2) Evaluate correlations and relationships of longitudinal normal and abnormal dLVAD pump operations data, to demographic and clinical variables. This study is the first study to evaluate HeartMate 3 ® dLVAD pump operations data over time for effectiveness in the clinical practice.
at UCSF
MIRACLE of LIFE Study
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The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?
at UCSD
TrEatment Approach in the Multimodal Era Registry
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The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH: - surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA)) - the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA)) - drugs Patients can also receive a combination of these treatments. The main question this registry aims to answer are: - How many patients receive a given kind of treatment? - How do expert centers combine the different treatments? - Are patients doing better after they receive a given kind of treatment? - How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment? Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.
at UCSD
Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism
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Potential outcomes after PE occur on a spectrum: complete recovery, exercise intolerance from deconditioning/anxiety, dyspnea from concomitant cardiopulmonary conditions, dyspnea from residual pulmonary vascular occlusion, chronic thromboembolic disease and chronic thromboembolic pulmonary hypertension. Although a battery of advanced diagnostic tests could distinguish each of those conditions, the yield of individual tests among all post- PE patients is low enough that routine testing of all PE patients is not typically performed. Although the various possible post-PE outcomes have enormous implications for patient care, they are rarely distinguished clinically. Perhaps for this reason, chronic conditions after PE are rarely (if ever) used as endpoints in randomized clinical trials of acute PE treatment. The proposed project will validate a clinical decision tree to distinguish among the various discrete outcomes cost-effectively through a hierarchical series of tests with the acronym SEARCH (for symptom screen, exercise function, arterial perfusion, resting heart function, confirmatory imaging and hemodynamics). Each step of the algorithm sorts a subset of patients into a diagnostic category unequivocally in a cost-effective manner. The categories are mutually exclusive and collectively exhaustive, so that each case falls into one, and only one, category. Each individual test used in the algorithm has been clinically validated in pulmonary embolism patients, including the cardiopulmonary exercise test (CPET) technique that the investigators developed and validated. However, the decision tree approach to deploying the tests has not yet been validated. Aim 1 will determine whether the SEARCH algorithm will yield concordant post-PE diagnoses when multiple reviewers independently evaluate multiple cases (reliability). Aim 2 will determine whether the post-PE diagnoses are stable, according to the SEARCH algorithm, between the first evaluation and the subsequent one six months later (validity).
at UC Davis UC Irvine UCLA UCSD UCSF
Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines
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To better understand postpartum blood pressure changes, we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who we know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. We expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.
at UCSD
Our lead scientists for High Blood Pressure research studies include Heather Siefkes Calvin H. Hirsch, MD Laura Gottlieb, MD, MPH Rushi Parikh, MD Suzanne Kafaja John Billimek, PhD James Brandt, MD Roblee P. Allen, MD Jennifer Lai, MD Timothy Fernandes, MD Elaine Ku, MD MAS Ying Han, MD Ronald Oudiz, MD Jeffrey Fineman, MD Pengbo Jiang, MD Mary Norton, MD Louise Laurent, MD, PhD Julius Oatts, MD Hythem Nawaytou, MD Edward Wolfgang Lee, MD Mehrdad Arjomandi Catherine A. Sarkisian Shaista Malik Alejandra Casillas, MD Jaime Deville Eyad Almasri Adam Brownstein, MD Richard Channick Arleen F Brown, MD, PhD Mark Pletcher, MD MPH Bassam Yaghmour, MD Courtney Lyles, PhD Miles Conrad, MD Cheryl A Anderson, PhD Urmimala Sarkar Rajan Saggar Timothy A Morris, MD Marni Jacobs, PhD Katie Longardner Ekamol Tantisattamo, MD, MPH Namita Sood Teresa De Marco, MD Marc Simon.
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