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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Hypertension Associated With HFpEF

In brief

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.

Key facts

Study ID

NCT07288398

Run by

Tenax Therapeutics, Inc.

People needed

540

Starts

2026-03-03

Expected to finish

2029-06-30

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men or women, ≥18 to 85 years of age
• NYHA Class II or III or ambulatory NYHA Class IV symptoms
• A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
• A qualifying baseline RHC
• A qualifying echocardiogram
• A qualifying 6-MWD
• A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
• Requirements related to child bearing potential, contraception, and egg/sperm donation)

You may not qualify if…

• A diagnosis of PH WHO Groups 1, 3, 4, or 5
• Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
• 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
• A diagnosis of pre-existing lung disease
• History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product
• Major surgery within 60 days
• Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
• History of clinically significant other diseases that may limit or complicate participation in the study

Where it is running

• Tenax Investigational Site — Reno, Nevada, United States (enrolling)
• Tenax Investigational Site — West Monroe, Louisiana, United States (enrolling)
• Tenax Investigational Site — Nashville, Tennessee, United States (enrolling)
• Tenax Investigational Site — Austin, Texas, United States (enrolling)
• Tenax Investigational Site — Alexander City, Alabama, United States (enrolling)
• Tenax Investigational Site — Peoria, Illinois, United States (enrolling)
• Tenax Investigational Site — New Orleans, Louisiana, United States (enrolling)
• Tenax Investigational Site — Winston-Salem, North Carolina, United States (enrolling)
• Tenax Investigational Site — Houston, Texas, United States (enrolling)
• Tenax Investigational Site — Dallas, Texas, United States (enrolling)
• Tenax Investigational Site — Vienna, Austria
• Tenax Investigational Site — Sofia, Bulgaria
• Tenax Investigational Site — Sofia, Bulgaria
• Tenax Investigational Site — Sofia, Bulgaria
• Tenax Investigational Site — Pleven, Bulgaria
• Tenax Investigational Site — Sankt Pölten, Austria
• Tenax Investigational Site — Braunau am Inn, Austria
• Tenax Investigational Site — Ribeirão Preto, São Paulo, Brazil
• Tenax Investigational Site — Nantes, France
• Tenax Investigational Site — Montpellier, France
• Tenax Investigational Site — Nice, France
• Tenax Investigational Site — Pau, France
• Tenax Investigational Site — Bad Bevensen, Germany
• Tenax Investigational Site — Bad Nauheim, Germany
• Tenax Investigational Site — Curitiba, Paraná, Brazil

Full record on ClinicalTrials.gov

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