LEVosimendan to Improve Exercise Limitation in Patients with PH-HFpEF
a study on High Blood Pressure Pulmonary Hypertension Heart Failure Left Ventricular Ejection Fraction
Summary
- Eligibility
- for people ages 18-85 (full criteria)
- Location
- at UCSF
- Dates
- study startedcompletion around
Description
Summary
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).
Official Title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Details
This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo
All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
Keywords
Pulmonary Hypertension, HFpEF, Pulmonary hypertension group 2, PH-HFpEF, Heart Failure, Hypertension, TNX-103
Eligibility
You can join if…
Open to people ages 18-85
- Men or women, greater than or equal to18 to 85 years of age.
- NYHA Class II or III or NYHA class IV symptoms.
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- Qualifying Baseline RHC.
- Qualifying echocardiogram
- Qualifying 6-MWD
- A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
- Requirements related to child bearing potential, contraception, and egg/sperm donation
You CAN'T join if...
- A diagnosis of PH WHO Groups 1, 3, 4, or 5.
- Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). OR, planned valve intervention. OR, the presence of significant valve disease
- A diagnosis of pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
- Major surgery within 60 days.
- Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
- History of clinically significant other diseases that may limit or complicate participation in the study.
Locations
- Tenax Investigational Site
accepting new patients
San Francisco California 94143 United States - Tenax Investigational Site
accepting new patients
La Jolla California 92037 United States - Tenax Investigational Site
accepting new patients
Los Angeles California 90048 United States - Tenax Investigational Site
accepting new patients
Irvine California 92868 United States - Tenax Investigational Site
accepting new patients
Los Angeles California 90033 United States - Tenax Investigational Site
accepting new patients
Sacramento California 95817 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Tenax Therapeutics, Inc.
- ID
- NCT05983250
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 230 study participants
- Last Updated