Phase 3 Study of Oral Levosimendan to Improve Exercise Ability in Adults With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

What this Trial Is About

Researchers are evaluating the efficacy and safety of the drug levosimendan, taken orally, compared to a placebo in adults with pulmonary hypertension associated with heart failure with preserved left ventricular ejection fraction PH-HFpEF. The main goal is to measure the change in the 6-Minute Walk Distance, which reflects exercise capacity. This phase 3, randomized, double-blind study aims to improve understanding of treatment options for this condition. About 540 participants will be randomly assigned in a 21 ratio to receive either oral levosimendan or a matching placebo. Those who complete the initial study period of 26 weeks may be eligible to join an open-label extension lasting 52 weeks, during which all participants can receive levosimendan. The study carefully monitors participants throughout both phases to assess the effects of the treatment. Participants will undergo various assessments including the 6-Minute Walk Distance test, questionnaires like the Kansas City Cardiomyopathy Questionnaire to evaluate health status, and classification of physical ability using the New York Heart Association scale. Screening includes heart catheterization, echocardiograms, ambulatory heart rhythm monitoring, and exercise testing. Safety and clinical worsening events will be tracked. The total involvement may last beyond a year for those in the extension phase, ensuring thorough evaluation of outcomes and safety.

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