RecruitingPulmonary Hypertension Associated With HFpEF
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Eligible age
18–85 yrs
Accepts
All genders
Locations
13 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Tenax Therapeutics, Inc.
You may qualify if…
- ✓ 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)
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07288398 · last updated 2026-03-16