Last updated 11 days 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, Spain

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