Trial · NCT02929329

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

NCT02929329, Phase 3, Completed, Cytokinetics; results first posted 2021-07-20

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction. Trials, record NCT02929329. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02929329

On this page

Trial

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

Title: Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
NCT number: NCT02929329
Status: Completed
Phases: Phase 3
Enrollment: 8,256 participants, actual
Lead sponsor: Cytokinetics
Conditions: Heart Failure
Interventions: Omecamtiv Mecarbil, Placebo, Standard of Care
First posted: 2016-10-11
Last updated: 2021-11-05
Other registries' IDs: eudract:2016-002299-28
Results first posted: 2021-07-20

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Time to Cardiovascular Death or First Heart Failure Event	From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis. A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy. All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials. Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.
Secondary	Time to Cardiovascular Death	From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes. All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials. Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.
Secondary	Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	Baseline and Week 24	The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms. The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient). Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates.
Secondary	Time to First Heart Failure Hospitalization	From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	A HF hospitalization is defined as an event that met all of the following criteria: 1. The participant was admitted to the hospital with a primary diagnosis of HF; 2. The length of stay in the hospital extended for at least 24 hours; 3. The participant exhibited documented new or worsening symptoms due to HF on presentation; 4. The participant had objective evidence of new or worsening HF; 5. The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal. Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials. Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported.
Secondary	Time to All-cause Death	From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials. Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Cardiovascular Death or First Heart Failure Event	From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	Full analysis set	percentage of participants	NUMBER
SECONDARY	Time to Cardiovascular Death	From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	Full analysis set	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	Baseline and Week 24	Full analysis set with available data	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Time to First Heart Failure Hospitalization	From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	Full analysis set	percentage of participants	NUMBER
SECONDARY	Time to All-cause Death	From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.	Full analysis set	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Value	Spread	Units
Time to Cardiovascular Death or First Heart Failure Event	Placebo	39.1		percentage of participants
Time to Cardiovascular Death or First Heart Failure Event	Omecamtiv Mecarbil	37.0		percentage of participants
Time to Cardiovascular Death	Placebo	19.4		percentage of participants
Time to Cardiovascular Death	Omecamtiv Mecarbil	19.6		percentage of participants
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	Placebo: Oupatients	6.29	Standard Error 0.34	scores on a scale
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	Omecamtiv Mecarbil: Outpatients	5.83	Standard Error 0.34	scores on a scale
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	Placebo: Inpatients	21.15	Standard Error 0.71	scores on a scale
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	Omecamtiv Mecarbil: Inpatients	23.65	Standard Error 0.70	scores on a scale
Time to First Heart Failure Hospitalization	Placebo	28.7		percentage of participants
Time to First Heart Failure Hospitalization	Omecamtiv Mecarbil	27.7		percentage of participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	4,112
Overall Study	STARTED	Omecamtiv Mecarbil	4,120
Overall Study	Received Treatment	Placebo	4,101
Overall Study	Received Treatment	Omecamtiv Mecarbil	4,110
Overall Study	COMPLETED	Placebo	3,008
Overall Study	COMPLETED	Omecamtiv Mecarbil	3,028
Overall Study	NOT COMPLETED	Placebo	1,104
Overall Study	NOT COMPLETED	Omecamtiv Mecarbil	1,092

Source ClinicalTrials.gov

Adverse events2,392

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	Placebo	291	4,101
other	Cardiac failure	Cardiac disorders	Omecamtiv Mecarbil	268	4,110
other	Hyperkalaemia	Metabolism and nutrition disorders	Placebo	213	4,101
other	Hyperkalaemia	Metabolism and nutrition disorders	Omecamtiv Mecarbil	202	4,110
other	Dizziness	Nervous system disorders	Placebo	183	4,101
other	Dizziness	Nervous system disorders	Omecamtiv Mecarbil	232	4,110
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Placebo	258	4,101
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Omecamtiv Mecarbil	249	4,110
other	Hypertension	Vascular disorders	Placebo	222	4,101
other	Hypertension	Vascular disorders	Omecamtiv Mecarbil	190	4,110

1 to 10 of 2,392Source ClinicalTrials.gov

See all 2,392 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1,078	4,112
Total, all-cause mortality	Omecamtiv Mecarbil	1,078	4,120
Total, other adverse events	Placebo	1,146	4,101
Total, other adverse events	Omecamtiv Mecarbil	1,129	4,110
Total, serious adverse events	Placebo	2,435	4,101
Total, serious adverse events	Omecamtiv Mecarbil	2,373	4,110

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32035892	DERIVED	PubMed
33185990	DERIVED	PubMed
34015475	BACKGROUND	PubMed
34643642	DERIVED	PubMed
35325102	DERIVED	PubMed
36597719	DERIVED	PubMed
37831045	DERIVED	PubMed
38215932	DERIVED	PubMed
41123512	DERIVED	PubMed
41528277	DERIVED	PubMed

1 to 10 of 13

See all 13 papers

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/NCT02929329

GET https://conductscience.org/api/trials/v1/NCT02929329/events?page=2

API reference For AI assistants