Trial · NCT03759392

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

NCT03759392, Phase 3, Completed, Cytokinetics; results first posted 2023-03-07

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure. Trials, record NCT03759392. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03759392

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure
NCT number: NCT03759392
Status: Completed
Phases: Phase 3
Enrollment: 276 participants, actual
Lead sponsor: Cytokinetics
Conditions: Heart Failure With Reduced Ejection Fraction
Interventions: Omecamtiv Mecarbil, Placebo
First posted: 2018-11-30
Last updated: 2023-03-07
Other registries' IDs: eudract:2018-001233-40
Results first posted: 2023-03-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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.
Secondary	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20	Baseline and Week 20	Full Analysis Set (all randomized participants who received at least 1 dose of randomized study drug)	mL/min/kg	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20	Baseline and Week 20	Full Analysis Set	Watt	LEAST_SQUARES_MEAN
SECONDARY	Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20	Baseline and Week 20	Full Analysis Set	slope	LEAST_SQUARES_MEAN
SECONDARY	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 analysis population included participants in the Full Analysis Set with available data at both assessment time frames (ie, baseline \[Week -2 to Day 1\] and Weeks 18-20).	10^5 activity units	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20	Omecamtiv Mecarbil	-0.239	Standard Error 0.1718	mL/min/kg
Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20	Placebo	0.207	Standard Error 0.2412	mL/min/kg
Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20	Omecamtiv Mecarbil	-3.798	Standard Error 1.3352	Watt
Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20	Placebo	1.590	Standard Error 1.9477	Watt
Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20	Omecamtiv Mecarbil	0.277	Standard Error 0.3616	slope
Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20	Placebo	-0.138	Standard Error 0.5065	slope
Change in the Average Daily Activity Units Measured Over a 2-week Period From Baseline (Week -2 to Day 1) to Weeks 18-20	Omecamtiv Mecarbil	-0.2	Standard Error 0.30	10^5 activity units
Change in the Average Daily Activity Units Measured Over a 2-week Period From Baseline (Week -2 to Day 1) to Weeks 18-20	Placebo	-0.5	Standard Error 0.38	10^5 activity units

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Omecamtiv Mecarbil	185
Overall Study	STARTED	Placebo	91
Overall Study	COMPLETED	Omecamtiv Mecarbil	164
Overall Study	COMPLETED	Placebo	85
Overall Study	NOT COMPLETED	Omecamtiv Mecarbil	21
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events142

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cardiac failure	Cardiac disorders	Omecamtiv Mecarbil	5	185
other	Cardiac failure	Cardiac disorders	Placebo	2	91
other	Angina pectoris	Cardiac disorders	Omecamtiv Mecarbil	4	185
other	Angina pectoris	Cardiac disorders	Placebo	3	91
other	Atrial fibrillation	Cardiac disorders	Omecamtiv Mecarbil	4	185
other	Atrial fibrillation	Cardiac disorders	Placebo	3	91
other	Palpitations	Cardiac disorders	Omecamtiv Mecarbil	0	185
other	Palpitations	Cardiac disorders	Placebo	2	91
other	Fatigue	General disorders	Omecamtiv Mecarbil	9	185
other	Fatigue	General disorders	Placebo	4	91

1 to 10 of 142Source ClinicalTrials.gov

See all 142 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Omecamtiv Mecarbil	3	185
Total, all-cause mortality	Placebo	1	91
Total, other adverse events	Omecamtiv Mecarbil	126	185
Total, other adverse events	Placebo	58	91
Total, serious adverse events	Omecamtiv Mecarbil	30	185
Total, serious adverse events	Placebo	13	91

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
35236099	DERIVED	PubMed
35852527	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Omecamtiv Mecarbil vs Placebo: deaths from any cause	Trial comparisons
Omecamtiv Mecarbil vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03759392

GET https://conductscience.org/api/trials/v1/NCT03759392/events?page=2

API reference For AI assistants