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Heart Failure clinical trials at UC Health
36 in progress, 21 open to new patients

  • A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)

    open to eligible people ages 45 years and up

    The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

    at UCLA

  • Adaptive Servo-Ventilation In Acute Heart Failure Patients Protecting the Heart and Kidneys

    open to eligible people ages 18 years and up

    The primary hypothesis of this study is: the use of minute ventilation-adaptive servo-ventilation (MV-ASV) during hospitalization will mitigate deterioration in renal function and prevent kidney injury in patients admitted with acute heart failure (AHF) compared to those receiving usual care. We will validate and extend our pilot study by taking a deeper dive into the effects of ASV on diuretic dose, urine output and new and exciting biomarkers of renal function and kidney injury. If our hypothesis proves correct, it strongly suggests that ASV lessens injury to the kidney and could lead to a new paradigm for the treatment of AHF. When use of high dose of diuretics are anticipated or in whom chronic kidney disease (CKD) or acute kidney injury (AKI) is present on arrival to the Emergency Department, use of MV-ASV might decrease the amount of diuretics needed, allow for continued use of ACE inhibitors, and ultimately mitigate rises in creatinine and decreases in effective glomerular filtration. Since kidney injury is a major factor in those patients with early 30-day readmission following discharge, this therapy could become quite popular.

    at UCSD

  • Cardiac Recovery Through Dietary Support

    open to eligible people ages 18 years and up

    This is a prospective, randomized, wait-list controlled study examining the impact of providing medically appropriate meals to patients discharged from Zuckerberg San Francisco General Hospital after acute decompensated heart failure. Upon discharge, patients will be randomized to either the intervention or wait list control arm. The intervention is the delivery of medically appropriate meals and groceries to patients' homes in a tapered manner over five months (the equivalent of three meals a day for 60 days, then the equivalent of two meals a day for 30 days, then the equivalent of one meal a day for 60 days) and monthly assessments with a registered dietician (RD). All food and RD assessments are administered via a community partner, Project Open Hand, as a modification of current offerings for clients at Project Open Hand. Subjects randomized into the wait list control arm will receive the food intervention five months after discharge. The study's primary aim is to examine the impact of nutritional support on the Kansas City Cardiomyopathy Questionnaire scores. In addition, the study aims to examine the impact of nutritional support on healthcare utilization (particularly readmission rates and emergency room utilization), dietary change, medication adherence, and quality of life.

    at UCSF

  • Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure.

    open to eligible people ages 18-80

    The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

    at UCLA UCSD

  • EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

    open to eligible people ages 18 years and up

    The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction

    at UCSF UC Irvine

  • EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced)

    open to eligible people ages 18 years and up

    The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.

    at UC Irvine

  • His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy

    open to eligible people ages 18 years and up

    The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in subjects with heart failure undergoing cardiac resynchronization therapy (CRT). While placement of left ventricular leads via the coronary sinus has anatomic limitations, we hypothesis that the achievement of QRS narrowing with His bundle capture will be superior for improving systolic function by echocardiographic indices (ejection fraction and strain) and quality of life and decreased rehospitalization and mortality.

    at UCLA

  • Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™

    open to eligible people ages 18 years and up

    This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional status, quality of life, and readmissions

    at UCLA

  • Mechanical Support Measures of Adjustment and QOL

    open to eligible people ages 19 years and up

    The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).

    at UCSF

  • MOMENTUM 3 Continued Access Protocol

    open to eligible people ages 18-100

    The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.

    at UCSD

  • Multiple Cardiac Sensors for the Management of Heart Failure

    open to eligible people ages 18 years and up

    The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

    at UCSF

  • Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (...

    open to eligible people ages 18-85

    This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.

    at UCLA UC Davis

  • Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

    open to eligible people ages 18 years and up

    The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF..

    at UCSF

  • Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency

    open to eligible people ages 18 years and up

    The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction.

    at UCLA UCSD

  • Study of high dose/low dose influenza vaccine to effectively stop heart or lung-related problems

    “Does high-dose influenza (“flu”) vaccine safely reduce heart or lung-related problems compared to the standard-dose flu vaccine?”

    open to eligible people ages 18 years and up

    INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.

    at UCSF UC Davis UCSD

  • Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

    open to eligible people ages 1 month to 17 years

    This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.

    at UCLA

  • Studying the Effects of Experimental "MitraClip Percutaneous Therapy" for Heart Failure Patients Who Need Mitral Valve Repair

    “If you have moderate-to-severe mitral regurgitation and cannot undergo mitral valve surgery, the MitraClip NT device may help you.”

    open to eligible people ages 18 years and up

    The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated study Primary Completion date is July 2018 and the Study Completion Date is July 2024. COAPT CAS is presently recruiting subjects.

    at UC Davis

  • Syncardia 50cc TAH-t as a Bridge to Transplant

    open to eligible people ages 10 years and up

    The primary objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probable benefit to, transplant-eligible pediatric patients (aged 10 - 18 years) and can safely and effectively support transplant-eligible adult patients (aged 19 - 75 years) at imminent risk of death from biventricular failure without experiencing permanent disabling, stroke-related deficits. The study will be conducted as a three-arm trial of the 50cc temporary Total Artificial Heart (TAH-t) as a bridge to transplant: - The Primary Pediatric Arm of the trial will evaluate the safety and probable benefit of the 50cc TAH-t for transplant-eligible patients 10 through 18 years of age. - The Primary Adult Arm of the trial will evaluate the safety and efficacy of the 50cc TAH-t for transplant-eligible patients 19 through 75 years of age. - The Secondary Arm will capture pediatric and adult subjects who did not meet enrollment criteria for a Primary Arm, but meet the less restrictive Secondary Arm enrollment criteria, in order to further characterize the use of the device.

    at UCLA

  • Technology-Based Intervention to Promote Heart Health After Cardiac Rehab (Mobile4Heart)

    open to eligible people ages 18 years and up

    The purpose of this study is to determine whether using a mobile app increases adherence to a heart healthy prescription after discharge from a cardiac rehab program.

    at UCSF

  • The Product Surveillance Registry REVERSE Post Approval Study

    open to all eligible people

    The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

    at UCSF

  • Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

    open to eligible people ages 18 years and up

    The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

    at UCSD UCLA

  • Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

    Sorry, in progress, not accepting new patients

    Lead survivability will be summarized.

    at UCSF

  • Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure

    Sorry, in progress, not accepting new patients

    The purpose of this trial is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy® with the BAROSTIM NEO® System in subjects with heart failure, defined as New York Heart Association (NYHA) functional class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or actively receiving Cardiac Resynchronization Therapy (CRT).

    at UCSF

  • Dynamic Heart Failure Prediction With Real-time Functional Status Data in the Ambulatory Setting

    Sorry, not yet accepting patients

    Heart failure is the number one cause of hospital readmission in those over 65 years of age and the current standard-of-care of weight self-monitoring is inadequate to predict exacerbation. This project aims to improve the monitoring of heart failure disease progression through the use of real-time, up-to-date data obtained both from a smart phone-based tool and from the electronic health record. The goal is to develop a low-risk, clinically validated method to estimate dynamic heart failure risk to enable the provision of earlier, more effective outpatient interventions that decrease hospitalization.

    at UCSF

  • Home Outpatient Monitoring and Engagement to Predict HF Exacerbation

    Sorry, accepting new patients by invitation only

    The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We will use a set of devices at home and surveys to collect information about patient's health. This study uses the Eureka app, a new study app developed by the University of California, San Francisco. The study is designed to happen remotely, using this application on a patient's smartphone, so that is as convenient as possible to participate.

    at UCSF

  • HW006 LATERAL Thoracotomy

    Sorry, in progress, not accepting new patients

    This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

    at UCSF UCSD

  • Model 4296 Left Ventricular (LV) Lead Chronic Performance Study

    Sorry, in progress, not accepting new patients

    Lead survivability will be summarized.

    at UCSF

  • Model 4396 Left Ventricular (LV) Lead Chronic Performance Study

    Sorry, in progress, not accepting new patients

    Lead survivability will be summarized.

    at UCSF

  • MOMENTUM 3 IDE Clinical Study Protocol

    Sorry, in progress, not accepting new patients

    The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

    at UCSD

  • Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

    Sorry, in progress, not accepting new patients

    This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.

    at UCLA UCSF

  • PRODIGY Registry in NYHA Class III Heart Failure Patients

    Sorry, not currently recruiting here

    This is an observational, prospective, single arm, multi-center registry to evaluate the Cordella™ Heart Failure System (CHFS) in up to 250 NYHA Class III HF patients .

    at UCSF

  • REDUCE LAP-HF TRIAL II

    Sorry, not currently recruiting here

    Multicenter, Prospective, Randomized Controlled, Blinded Trial, with a Non-implant Control group; 1:1 randomization.

    at UCLA

  • Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure

    Sorry, not yet accepting patients

    This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure

    at UCSF

  • Social Engagement Strategies to Improve Medication Adherence

    Sorry, not yet accepting patients

    In this pilot study, investigators, in partnership with Resource Centers for Minority Aging Research (RCMAR) mentorship team and the MyMeds program, will enroll patients from MyMeds with diabetes, atherosclerotic cardiovascular disease, or congestive heart failure with poor medication adherence (medication adherence percentage<80% for statin or antihypertensive therapy) who report having a least one loved one or friend (e.g., spouse) whom they consider to be invested in their health, and with whom they would be willing to share focused medical information about medication adherence in the form of text messages. They will randomize these patients to private feedback about medication adherence or social network feedback about medication adherence. Investigators will evaluate the effects of this social network intervention on medication adherence and examine the program's acceptability among study participants. This proposal is innovative because it leverages social networks—largely unused in medical care—for health improvement.

    at UCLA

  • To Assess Safety and Efficacy of Myoblast Implantation Into Myocardium Post Myocardial Infarction

    Sorry, in progress, not accepting new patients

    This study injects a person's own stem cells into heart muscle tissue after a person has one or more heart attacks. The purpose of the study is whether the stem cells will improve a patient's heart performance.

    at UCSD

  • Tunneled Pleural Catheters for Refractory Effusions Attributed to Congestive Heart Failure (TREAT-CHF) Trial

    Sorry, not yet accepting patients

    Congestive heart disease (CHF) can frequently cause transudative pleural effusions, some of which do not completely resolve with diuretics alone. These effusions can cause significant morbidity, leading to ongoing dyspnea and hypoxia, resulting in additional office and hospital visits. TREAT-CHF is a randomized trial studying tunneled pleural catheter (TPC) versus standard medical management for the treatment recurrent symptomatic pleural effusions secondary to CHF that are refractory to maximal medical therapy. TREAT-CHF will study whether the addition of a TPC can improve quality of life and minimize health care utilization over the one year following insertion.

    at UCLA

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