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Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction | Clinical Trials | Clareo Health

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

NCT02929329•Cytokinetics

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

Detailed Description

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has provided informed consent
•Male or female, ≥ 18 to ≤ 85 years
•History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
•Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
•New York Heart Association (NYHA) class II to IV at most recent screening assessment.
•Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
•Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
•Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Exclusion Criteria

•Currently receiving treatment in another investigational device or drug study, or \< 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
•Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
•Subject has known sensitivity to any of the products or components to be administered during testing

Locations (1033)

Research Site

Birmingham, Alabama, United States

Research Site

Birmingham, Alabama, United States

Research Site

Birmingham, Alabama, United States

Research Site

Fort Payne, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Mobile, Alabama, United States

Research Site

Scottsboro, Alabama, United States

Research Site

Tuscumbia, Alabama, United States

Research Site

Gilbert, Arizona, United States

Research Site

Phoenix, Arizona, United States

Key Dates

Start Date

January 6, 2017

Primary Completion Date

September 14, 2020

Completion Date

September 14, 2020

Last Updated

November 5, 2021

Enrollment

8,256

ACTUAL participants

Conditions

Heart Failure

Interventions

Omecamtiv Mecarbil

DRUG

Placebo

DRUG

Standard of Care

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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