Recruiting

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

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.

ClinicalTrials.gov IDNCT07288398

PhasePHASE3

Enrollment540

SponsorTenax Therapeutics, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pulmonary Hypertension Associated With HFpEF

About this study

Interventions

Drug: TNX-103 — Oral levosimendan
Drug: Placebo — Matching placebo (oral)

Primary outcomes

6-Minute Walk Distance (6MWD) (26 weeks)

Eligibility information

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

Study locations

Tenax Investigational Site, Alexander City, Alabama 35010 United States
Tenax Investigational Site, Tucson, Arizona 85724 United States
Tenax Investigational Site, Sacramento, California 95816 United States
Tenax Investigational Site, San Francisco, California 94143 United States
Tenax Investigational Site, Stanford, California 94305-5208 United States
Tenax Investigational Site, Torrance, California 90502 United States
Tenax Investigational Site, Athens, Georgia 30606 United States
Tenax Investigational Site, Atlanta, Georgia 30322 United States
Tenax Investigational Site, Chicago, Illinois 60611-4494 United States
Tenax Investigational Site, Chicago, Illinois 60637 United States

Showing 10 of 141 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.