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Levosimendan to improve exercise ability in people with pulmonary hypertension from HFpEF

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction

Phase 3 Interventional Tenax Therapeutics, Inc. · NCT07288398

This test tries an oral drug called levosimendan to see if it helps people with pulmonary hypertension due to HFpEF walk farther on a 6-minute walk than a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorTenax Therapeutics, Inc. Industry-sponsored
Locations92 sites (Alexander City, Alabama and 91 other locations)
Trial IDNCT07288398 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, double-blind trial will enroll about 540 adults with WHO Group 2 pulmonary hypertension secondary to HFpEF and randomize them 2:1 to oral levosimendan or placebo. Eligibility requires hemodynamic confirmation by right heart catheterization, a qualifying echocardiogram, and a baseline 6-minute walk distance, with ambulatory rhythm monitoring during screening. The primary outcome is change in 6-minute walk distance; participants who complete the double-blind period may enter a 52-week open-label extension. The study is sponsored by Tenax Therapeutics and conducted at company investigational sites in the U.S.

Who should consider this trial

Good fit: Adults aged 18–85 with WHO Group 2 pulmonary hypertension due to HFpEF, NYHA class II–III (or ambulatory IV), and qualifying right heart catheterization, echocardiogram, and 6-minute walk test are ideal candidates.

Not a fit: Patients with other types of pulmonary hypertension (WHO Groups 1, 3, 4, or 5), significant valve disease or prior valve replacement, certain cardiomyopathies, or pre-existing lung disease are unlikely to benefit from this treatment.

Why it matters

Potential benefit: If successful, levosimendan could improve exercise capacity and daily functioning for people with PH-HFpEF.

How similar studies have performed: Earlier-phase and smaller studies of levosimendan in heart failure have shown mixed but sometimes encouraging effects on exercise capacity, but oral levosimendan specifically for PH-HFpEF is relatively novel and is now being tested in this larger Phase 3 effort.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Alexander City, Alabama and 91 other locations

+42 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Hypertension Associated With HFpEFPH-HFpEFlevosimendanHFpEFHeart FailurePulmonary Hypertension Group 2
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.