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LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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
About the 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.
What is being tested
- TNX-103 (drug)
- Placebo (drug)
Sponsor: Tenax Therapeutics, Inc. · Participants: 540 · Started: Mar 3, 2026
Contact the study team
- Akshata Ashokkumar · Phone: (919) 855-2118
- Katelyn Jansson · Phone: (919) 855-2119
Official record on ClinicalTrials.gov — NCT07288398
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.