Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure With Reduced Ejection Fraction

In brief

The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo

Key facts

Study ID

NCT03759392

Run by

Cytokinetics

People needed

276

Starts

2019-04-09

Expected to finish

2022-01-06

Last updated by the study team

2023-03-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, greater than or equal to 18 to lesser than or equal to 85 years of age
• History of chronic HF, defined as requiring continuous treatment with medications for HF for a minimum of 3 months before screening
• New York Heart Association (NYHA) class II or III at screening
• Left ventricular ejection fraction less than or equal to 35%
• On maximally tolerated HF standard of care (SoC) therapies consistent with regional clinical practice guidelines, if not contraindicated and according to investigator judgment of the subject's clinical status. Beta blocker dose must be stable for 30 days prior to randomization.
• N-terminal (NT)-proBNP level greater than or equal to 200 pg/mL
• Peak VO2 less than or equal to 75% of the predicted normal value with respiratory exchange ratio (RER) greater than or equal to 1.05 on a screening CPET, confirmed by a CPET core laboratory

You may not qualify if…

• Severe uncorrected valvular heart disease
• Paroxysmal atrial fibrillation or flutter documented within the previous 6 months, direct-current (DC) cardioversion or ablation procedure for atrial fibrillation within 6 months, or plan to attempt to restore sinus rhythm within 6 months of randomization. Subjects with persistent atrial fibrillation and no sinus rhythm documented in the prior 6 months are permitted.
• Symptomatic bradycardia, second-degree Mobitz type II, or third-degree heart block without a pacemaker.
• History of gastrointestinal bleeding requiring hospitalization, urgent procedure or transfusion in the prior year, or received intravenous (IV) iron, blood transfusion, or an erythropoiesis-stimulating agent (ESA) within 3 months prior to screening, or planned blood transfusion or ESA use during the study screening or treatment period. Chronic, stable use of oral iron is permitted.
• Ongoing or planned enrollment in cardiac rehabilitation.
• Requires assistance to walk or use of mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable if the subject is deemed capable of performing CPET.
• Major medical event or procedure within 3 months prior to randomization, including: hospitalization, surgery, renal replacement therapy or cardiac procedure. This includes episodes of decompensated HF that require IV HF treatment.
• At screening: Resting systolic BP greater than 140 mmHg or less than 85 mmHg, or diastolic BP greater than 90 mmHg (mean of triplicate readings); Resting heart rate greater than 90 beats per minute, or less than 50 beats per minute (mean of triplicate readings); Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 (by the modified Modification of Diet in Renal Disease equation); Hepatic impairment defined by a total bilirubin (TBL) greater than or equal to 2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times ULN. Patients with documented Gilbert syndrome and TBL greater than or equal to 2 times ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
• Room air oxygen saturation under 90% at screening
• Hemoglobin less than 10.0 g/dL at screening
• Significant adverse finding (e.g., exercise-induced early ischemic changes, abnormal decrease in BP [systolic BP falls by more than 10 mmHg], unexpected arrhythmia or other serious finding) during CPET at screening that precludes safe participation in the study, per investigator
• Chronotropic incompetence (including inadequate pacemaker rate response) during CPET at screening, defined as a maximum heart rate <60% of the maximum predicted heart rate

Where it is running

• Arkansas Cardiology Clinic — Little Rock, Arkansas, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• South Denver Cardiology Associates, PC — Littleton, Colorado, United States
• Hartford Hospital-University of Connecticut School of Medicine — Hartford, Connecticut, United States
• Holy Cross Hospital - Fort Lauderdale — Fort Lauderdale, Florida, United States
• Broward Research Center - Pembroke Pines — Pembroke Pines, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Community Hospital South, Inc. — Indianapolis, Indiana, United States
• Saint Vincent Medical Group Inc. — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital (MGH) - Cardiac Unit Associates — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Heart & Vascular Institute — Detroit, Michigan, United States
• McLaren Health Care Corporation — Petoskey, Michigan, United States
• Michigan Heart — Ypsilanti, Michigan, United States
• Saint Luke's Health System — Kansas City, Missouri, United States
• Glacier View Research Institute, Cardiology — Kalispell, Montana, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer — Elmer, New Jersey, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• NYU Langone Medical Center — New York, New York, United States
• Queens Heart Institute — Rosedale, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Med Health and Hospital — Raleigh, North Carolina, United States
• Alaska Heart and Vascular Institute — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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