SERENADE/AC-055-G202 study - Macitentan in Heart Failure, A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease
IRB Protocol #: 1710018707
Overview: There are several drugs available to manage heart failure symptoms, but to date, no treatments have been approved specifically for left heart failure with preserved ejection fraction and pulmonary vascular disease. The purpose of this study is to find out whether macitentan works and is safe in this disease.
This trial is funded by Actelion Pharmaceuticals Ltd.
Eligible patients must have:
• Left ventricular ejection fraction (LVEF) ≥ 40%
• New York Heart Association (NYHA) functional class (FC) II to III
Patients cannot participate if they have:
• Any prior measurement of LVEF < 40%
• Known indication for PCI or CABG
Dr. Evelyn Horn
Phone: (212) 746-2381
Melissa Ricketts, MSHS, CCRC
Phone: (212) 746-2698