Last updated 2 months ago
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
540 patients around the world
Available in Argentina, United States, Brazil
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose
of levosimendan or placebo. Participants will be eligible for an open label extension
(OLE) of 52-weeks.
Tenax Therapeutics, Inc.
540Patients around the world
This study is for people with
Pulmonary hypertension
Pulmonary arterial hypertension
Heart failure
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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.
- 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.
StudyLEVEL-2
SponsorTenax Therapeutics, Inc.
Study typeInterventional
Conditions
Pulmonary arterial hypertensionHeart failure
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07288398
