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The primary endpoint is the change in peak oxygen uptake (pVO2) on CPET from baseline to Week 20. #Cardiac index to ejection fraction converter trialPatients were randomized in a 2:1 fashion to omecamtiv mecarbil, starting at 25 mg twice daily and titrated to 25, 37.5 or 50 mg twice daily based on the same PK-guided dosing regimen as used in GALACTIC-HF, the Phase 3 cardiovascular outcomes trial of omecamtiv mecarbil, or to placebo. Patients are required to have a left ventricular ejection fraction (LVEF) ≤35 percent, New York Heart Association (NYHA) heart failure class II or III and reduced exercise capacity compared to age matched controls. METEORIC-HF opened to enrollment in early 2019 and was designed to enroll 270 patients with HFrEF at sites throughout the U.S., Canada and Europe to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by CPET. #Cardiac index to ejection fraction converter Activator“We look forward to assessing whether improvement in cardiac contractility by a novel mechanism cardiac myosin activator may increase exercise capacity and potentially lead to greater mobility and function for patients living with HFrEF.” “Exercise intolerance is a common symptom among people suffering from heart failure with reduced ejection fraction and can seriously limit quality of life,” said Gregory Lewis, M.D., Heart Failure Section Head and Director, Cardiopulmonary Exercise Testing Laboratory, Massachusetts General Hospital. ![]() Results from METEORIC-HF are expected in early 2022 and may further elaborate on potential effects in patients with severe heart failure.” “Based on recent interactions with FDA, we plan to submit the New Drug Application for omecamtiv mecarbil this year based on results from GALACTIC-HF. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We would like to thank the investigators and clinical site coordinators for their commitment to METEORIC-HF, particularly given the challenges they overcame enrolling a trial in the midst of a global pandemic,” said Fady I. ![]()
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