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

RecruitingPhase 3

Sponsor: Tenax Therapeutics, Inc.

Conditions: Pulmonary Hypertension Associated With HFpEF

Interventions: TNX-103, Placebo

Countries: United States, Argentina, Austria, Brazil, Bulgaria, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (141)

Alexander City, Alabama, United States
Tucson, Arizona, United States
Sacramento, California, United States
San Francisco, California, United States
Stanford, California, United States
Torrance, California, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Mount Prospect, Illinois, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
West Monroe, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Ypsilanti, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
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