Mount Prospect

Researchers are studying the drug levosimendan taken orally to evaluate its safety and effectiveness 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 see if levosimendan improves exercise ability, measured by the change in the distance walked in six minutes. This is a Phase 3 clinical trial involving approximately 540 participants. Participants will be randomly assigned in a 2:1 ratio to receive either oral levosimendan or a matching placebo. After the initial study period, those who qualify may join an open-label extension lasting 52 weeks to continue receiving the study drug. The study carefully monitors the participants' health and responses during these phases. Throughout the trial, participants will undergo various assessments including right heart catheterization, echocardiograms, and a six-minute walk test to measure exercise capacity. Heart rhythm will be monitored using a 48-hour ambulatory cardiac monitor during screening. Safety and effectiveness are tracked over at least 26 weeks, with the primary measurement being the six-minute walk distance. Participants may be followed for up to a year if they enter the extension phase.