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

RecruitingPhase 3

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

Sponsor: Tenax Therapeutics, Inc. · Participants: 540 · Started: Mar 3, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07288398

Locations in the U.S.

AlabamaTenax Investigational Site, Alexander City
ArizonaTenax Investigational Site, Tucson (Not yet recruiting)
CaliforniaTenax Investigational Site, Sacramento (Not yet recruiting)
Tenax Investigational Site, San Francisco (Not yet recruiting)
Tenax Investigational Site, Stanford (Not yet recruiting)
Tenax Investigational Site, Torrance (Not yet recruiting)
GeorgiaTenax Investigational Site, Athens (Not yet recruiting)
Tenax Investigational Site, Atlanta (Not yet recruiting)
IllinoisTenax Investigational Site, Chicago (Not yet recruiting)
Tenax Investigational Site, Chicago (Not yet recruiting)
Tenax Investigational Site, Mount Prospect (Not yet recruiting)
Tenax Investigational Site, Peoria
IndianaTenax Investigational Site, Indianapolis
LouisianaTenax Investigational Site, New Orleans
Tenax Investigational Site, West Monroe
MassachusettsTenax Investigational Site, Boston (Not yet recruiting)
MichiganTenax Investigational Site, Ann Arbor (Not yet recruiting)
Tenax Investigational Site, Ypsilanti
MinnesotaTenax Investigational Site, Minneapolis (Not yet recruiting)
Tenax Investigational Site, Rochester (Not yet recruiting)
MissouriTenax Investigational Site, Kansas City (Not yet recruiting)
Tenax Investigational Site, St Louis (Not yet recruiting)
NebraskaTenax Investigational Site, Omaha
NevadaTenax Investigational Site, Reno
New YorkTenax Investigational Site, New York
Tenax Investigational Site, New York
Tenax Investigational Site, Rochester
North CarolinaTenax Investigational Site, Durham
Tenax Investigational Site, Winston-Salem
OhioTenax Investigational Site, Cleveland (Not yet recruiting)
Tenax Investigational Site, Columbus (Not yet recruiting)
PennsylvaniaTenax Investigational Site, Allentown (Not yet recruiting)
Tenax Investigational Site, Pittsburgh (Not yet recruiting)
Tenax Investigational Site, Wynnewood (Not yet recruiting)
South CarolinaTenax Investigational Site, Charleston (Not yet recruiting)
TennesseeTenax Investigational Site, Nashville
TexasTenax Investigational Site, Austin
Tenax Investigational Site, Dallas
Tenax Investigational Site, El Paso (Not yet recruiting)
Tenax Investigational Site, Houston (Not yet recruiting)
VirginiaTenax Investigational Site, Charlottesville (Not yet recruiting)
Tenax Investigational Site, Norfolk (Not yet recruiting)
WashingtonTenax Investigational Site, Seattle (Not yet recruiting)
WisconsinTenax Investigational Site, Madison (Not yet recruiting)
Tenax Investigational Site, Marshfield

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.