LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Description

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).

Conditions

Pulmonary Hypertension

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Study Overview

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Study Details

Study overview

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).

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)

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Condition
Pulmonary Hypertension
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

Irvine

University of California, Irvine, California, United States, 92868

Sacramento

UC Davis Health Medical Center, Sacramento, California, United States, 95817

Sacramento

University of California- Davis Medical Center, Sacramento, California, United States, 95817

San Francisco

University of California, San Francisco, California, United States, 94143

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Jacksonville

Mayo Clinic, Jacksonville, Florida, United States, 32224

Winter Haven

Winter Haven Hospital, Winter Haven, Florida, United States, 33881

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Chicago

Northwestern University, Chicago, Illinois, United States, 60208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Men or women, greater than or equal to18 to 85 years of age.
  • 2. NYHA Class II or III or NYHA class IV symptoms.
  • 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
  • 4. Qualifying Baseline RHC.
  • 5. Qualifying echocardiogram
  • 6. Qualifying 6-MWD
  • 7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
  • 8. Requirements related to child bearing potential, contraception, and egg/sperm donation
  • 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
  • 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  • 3. 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
  • 4. A diagnosis of pre-existing lung disease
  • 5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
  • 6. Major surgery within 60 days.
  • 7. Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months
  • 8. History of clinically significant other diseases that may limit or complicate participation in the study.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tenax Therapeutics, Inc.,

Study Record Dates

2027-07