RecruitingPhase 3

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

United States230 participantsStarted 2024-01-10

Plain-language 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).

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Change in Six-minute walk distance

Timeframe: 12 weeks

Trial details

NCT IDNCT05983250

SponsorTenax Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Kevin Crawford

19198552145 k.crawford@tenaxthera.com

View on ClinicalTrials.gov More Pulmonary Hypertension trials