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

Phase 3

Completed

Brief Summary: 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

Detailed Description: Oversight Authorities:

United States: Food and Drug Administration Canada: Health Canada France: National Agency for the Safety of Medicine and Health Products Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy and Nutrition Italy: Italian Medicines Agency Netherlands: Medicines Evaluation Board Poland: Chief Pharmaceutical Inspectorate Sweden: Medical Products Agency

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Omecamtiv Mecarbil	Omecamtiv Mecarbil	Omecamtiv mecarbil was administered as an oral modified-release tablet twice daily for up to 20 weeks. Participants randomized to this arm started at an omecamtiv mecarbil dose of 25 mg twice daily. The dose could be increased based on plasma concentrations at Weeks 2 and 6.
Placebo	Placebo	Participants randomized this arm received placebo tablets (matching the appearance of the omecamtiv mecarbil tablets) twice daily for up to 20 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20	Baseline and Week 20	The effect of treatment on exercise capacity, as assessed by peak oxygen uptake, was assessed during cardiopulmonary exercise testing (CPET) with gas-exchange analysis. Cycle ergometry was the preferred modality for exercise testing; treadmill exercise testing was an acceptable alternative. Participants were to use the same testing modality for all exercise tests during the study. Whenever possible, CPET was administered by the same study personnel using the same equipment throughout the study.

Secondary Outcome Measures

Name	Time	Method
Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20	Baseline and Week 20	Total workload was measured during CPET (cycle ergometry \[preferred\] or treadmill exercise testing) and represents the maximum load to which a participant was subjected during CPET in order to produce work.
Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20	Baseline and Week 20	Ventilatory efficiency (ventilation \[VE\]/volume of exhaled carbon dioxide \[VCO2\]) was measured through CPET with gas exchange analysis.
Change in the Average Daily Activity Units Measured Over a 2-week Period From Baseline (Week -2 to Day 1) to Weeks 18-20	Baseline (Week -2 to Day 1) to Weeks 18-20	The effect of treatment on daily activity, as assessed by average daily activity units, was evaluated by actigraphy. Actigraphy was collected during 4 sessions throughout the study for 2 week intervals.

Locations (81): Alaska Heart and Vascular Institute
🇺🇸
Anchorage, Alaska, United States
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
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Alaska Heart and Vascular Institute
🇺🇸Anchorage, Alaska, United States