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Active, not recruiting Phase 3

LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

NCT07288398 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2026-03-03
Last updated
2026-10-15

Condition(s) studied

Pulmonary Hypertension Associated With HFpEF

Investigational drug(s) / intervention(s)

TNX-103 →Placebo

TNX-103: Oral levosimendan

Placebo: Matching placebo (oral)

Study summary

The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men or women, ≥18 to 85 years of age 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC) 4. A qualifying baseline RHC 5. A qualifying echocardiogram 6. A 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) Exclusion Criteria: 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

Primary outcome measure(s)

  • 6-Minute Walk Distance (6MWD) — 26 weeks
    Change in 6-minute walk distance

Trial sites (140)

FacilityCityRegionStatus
Tenax Investigational Site Alexander City Alabama
Tenax Investigational Site Tucson Arizona
Tenax Investigational Site Sacramento California
Tenax Investigational Site San Francisco California
Tenax Investigational Site Stanford California
Tenax Investigational Site Torrance California
Tenax Investigational Site Athens Georgia
Tenax Investigational Site Atlanta Georgia
Tenax Investigational Site Chicago Illinois
Tenax Investigational Site Chicago Illinois
Tenax Investigational Site Mount Prospect Illinois
Tenax Investigational Site Peoria Illinois
Tenax Investigational Site Indianapolis Indiana
Tenax Investigational Site New Orleans Louisiana
Tenax Investigational Site West Monroe Louisiana
Tenax Investigational Site Boston Massachusetts
Tenax Investigational Site Ann Arbor Michigan
Tenax Investigational Site Ypsilanti Michigan
Tenax Investigational Site Minneapolis Minnesota
Tenax Investigational Site Rochester Minnesota
Tenax Investigational Site Kansas City Missouri
Tenax Investigational Site St Louis Missouri
Tenax Investigational Site Omaha Nebraska
Tenax Investigational Site Reno Nevada
Tenax Investigational Site New York New York
Tenax Investigational Site New York New York
Tenax Investigational Site Rochester New York
Tenax Investigational Site Durham North Carolina
Tenax Investigational Site Winston-Salem North Carolina
Tenax Investigational Site Cleveland Ohio
Tenax Investigational Site Columbus Ohio
Tenax Investigational Site Allentown Pennsylvania
Tenax Investigational Site Pittsburgh Pennsylvania
Tenax Investigational Site Wynnewood Pennsylvania
Tenax Investigational Site Charleston South Carolina
Tenax Investigational Site Nashville Tennessee
Tenax Investigational Site Austin Texas
Tenax Investigational Site Dallas Texas
Tenax Investigational Site El Paso Texas
Tenax Investigational Site Houston Texas

+ 100 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07288398 on ClinicalTrials.gov ↗ ← All trials in France