LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension

In brief

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).

Key facts

Study ID

NCT05983250

Run by

Tenax Therapeutics, Inc.

People needed

230

Starts

2024-01-10

Expected to finish

2028-10-30

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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