RecruitingPhase 3NCT05983250

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

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)

Sponsor

Tenax Therapeutics, Inc.

Enrollment

230 participants

Start Date

Jan 10, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension

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).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing levosimendan — a drug normally used for heart failure — to see whether it can improve the ability to exercise in people who have pulmonary hypertension related to heart failure with preserved ejection fraction (PH-HFpEF). This is a condition where high blood pressure in the lungs is caused by a stiff, poorly relaxing heart. **You may be eligible if:** - You are 18–85 years old - You have been diagnosed with WHO Group 2 pulmonary hypertension related to heart failure with preserved ejection fraction (HFpEF) - You have NYHA Class II–IV symptoms (ranging from mild to severe breathlessness) - Your heart measurements on testing meet specific qualifying criteria **You may NOT be eligible if:** - You have a different type of pulmonary hypertension (Groups 1, 3, 4, or 5) - You have had major heart valve surgery or are planning it - You have pre-existing significant lung disease - You have had major surgery in the last 60 days or a prior heart/lung transplant - You have a life expectancy of less than 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTNX-103

oral levosimendan 1 mg

DRUGPlacebo

Placebo

Locations(44)

Tenax Investigational Site

Tucson, Arizona, United States

Tenax Investigational Site

La Jolla, California, United States

Tenax Investigational Site

Los Angeles, California, United States

Tenax Investigational Site

Los Angeles, California, United States

Tenax Investigational Site

Sacramento, California, United States

Tenax Investigational Site

San Francisco, California, United States

Tenax Investigational Site

Torrance, California, United States

Tenax Investigational Site

Jacksonville, Florida, United States

Tenax Investigational Site

Winter Haven, Florida, United States

Tenax Investigational Site

Atlanta, Georgia, United States

Tenax Investigational Site

Chicago, Illinois, United States

Tenax Investigational Site

Chicago, Illinois, United States

Tenax Investigational Site

Galesburg, Illinois, United States

Tenax Investigational Site

Indianapolis, Indiana, United States

Tenax Investigational Site

Indianapolis, Indiana, United States

Tenax Investigational Site

Louisville, Kentucky, United States

Tenax Investigational Site

Boston, Massachusetts, United States

Tenax Investigational Site

Minneapolis, Minnesota, United States

Tenax Investigational Site

Rochester, Minnesota, United States

Tenax Investigational Site

St Louis, Missouri, United States

Tenax Investigational Site

Omaha, Nebraska, United States

Tenax Investigational Site

New York, New York, United States

Tenax Investigational Site

New York, New York, United States

Tenax Investigational Site

Rochester, New York, United States

Tenax Investigational Site

Roslyn, New York, United States

Tenax Investigational Site

Charlotte, North Carolina, United States

Tenax Investigational Site

Durham, North Carolina, United States

Tenax Investigational Site

Greensboro, North Carolina, United States

Tenax Investigational Site

Cincinnati, Ohio, United States

Tenax Investigational Site

Columbus, Ohio, United States

Tenax Investigational Site

Pittsburgh, Pennsylvania, United States

Tenax Investigational Site

Providence, Rhode Island, United States

Tenax Investigational Site

Charleston, South Carolina, United States

Tenax Investigational Site

Columbia, South Carolina, United States

Tenax Investigational Site

Dallas, Texas, United States

Tenax Investigational Site

Dallas, Texas, United States

Tenax Investigational Site

Lubbock, Texas, United States

Tenax Investigational Site

Plano, Texas, United States

Tenax Investigational Site

Murray, Utah, United States

Tenax Investigational Site

Richmond, Virginia, United States

Tenax Investigational Site

Madison, Wisconsin, United States

Tenax Investigational Site

Winnipeg, Manitoba, Canada

Tenax Investigational Site

London, Ontario, Canada

Tenax Investigational Site

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT05983250

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