Phase 2 Feasibility Study of Empagliflozin and Ranolazine for Pulmonary Hypertension with Right Heart Failure

What this Trial Is About

Researchers are evaluating the feasibility of a larger platform trial called CRAVE to test multiple treatments aimed at improving right ventricular function in people with pulmonary hypertension and right heart failure. This phase 2, randomized, open-label trial will include 30 participants to compare the effects of empagliflozin, ranolazine, both added to standard care, against standard care alone. The study seeks to determine whether a larger trial can be successfully conducted by assessing recruitment, consent, and data collection processes. Participants will be randomly assigned to one of three groups empagliflozin 10 mg once daily plus standard care, ranolazine starting at 500 mg twice daily then increasing to 1000 mg twice daily after two weeks or 500 mg twice daily if taking certain other medications plus standard care, or standard care alone. The treatment period lasts 16 weeks, during which participants will be monitored and their outcomes recorded. During the 16-week study, participants will undergo various assessments including medical record review to track right ventricular function, exercise capacity both virtual and in-person, biomarker levels, hemodynamics, and quality of life using several questionnaires. Researchers will also monitor enrollment rates, loss to follow-up, and ability to gather comprehensive data. This thorough monitoring aims to inform the design of a larger future trial. Participation involves regular follow-up and data collection but no blinding or placebo control.

Feasibility Trial for a Right Ventricular Failure Platform Trial