Recruiting
Sponsor ID
CY 1031

Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects with Heart FailureMETEORIC-HF

Sponsor ID
CY 1031
Clinicaltrials.gov ID
NCT03759392
EUCTIS ID
N/A
EudraCT ID
2018-001233-40

Study Details

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

Additional Study Details

Phase
Phase 3
Product
AMG 423
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
270
Additional Study Details

Protocol Summary

Primary Outcome Measures

Change in peak oxygen uptake (VO2) on cardiopulmonary exercise testing from baseline to Week 20

Timeframe: Week 20

Secondary Outcome Measures

Change in exercise capacity, as measured by the change in total workload during cardiopulmonary exercise testing (CPET) from baseline to Week 20

Timeframe: Week 20

Change in ventilatory efficiency, as measured by the change in Ventilation (VE)/Carbon dioxide output (VCO2) slope during cardiopulmonary exercise testing (CPET) from baseline to Week 20

Timeframe: Week 20

Change in the average daily activity units measured over a 2-week period from baseline (Week -2 to Day 1) to Week 18-20

Timeframe: Week 20

Locations

Location
Status
Contact Us
Location
Harbor-UCLA Medical Center
Torrance, California, United States, 90509
16.3 miles (26.1 km) away from your location
Status
Recruiting