RECRUITING

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction

Conditions

Heart Failure Heart Failure With Reduced Ejection Fraction CK-1827452 omecamtiv mecarbil

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

Official Title

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

Quick Facts

Study Start:2024-12

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06736574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Are between ≥ 18 years and ≤ 85 years at the signing of informed consent * Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening * Are receiving oral loop diuretics * Have a left ventricular ejection fraction (LVEF) \< 30% measured within the prior 6 months * Are currently hospitalized with the primary reason of HF, or had an HF event within 6 months prior to screening * Are established on regional standard-of-care HF therapies for at least 30 days prior to screening * Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 mmHg * Have elevated natriuretic peptide levels (B-type natriuretic peptide \[BNP\] or N-terminal prohormone of B-type natriuretic peptide \[NT-proBNP\]) at screening: 1. Patients without AFF on the screening electrocardiogram (ECG): BNP ≥ 300 pg/mL or NT-proBNP ≥ 1,000 pg/mL 2. Patients with AFF on the screening ECG: BNP ≥ 900 pg/mL or NT-proBNP ≥ 3,000 pg/mL	* Have AFF on the screening ECG and are currently taking digoxin * Have had acute coronary syndrome, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization therapy within 3 months of screening * Are admitted to a long-term care facility or hospice * Have a projected survival of \< 12 months due to non-cardiovascular causes based on clinical judgment * Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening * Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening * Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening * Have an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 or receiving dialysis at screening * Have previously had a solid organ transplant * Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening * Have previously received omecamtiv mecarbil * Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP

Inclusion Criteria

Exclusion Criteria

* Are between ≥ 18 years and ≤ 85 years at the signing of informed consent
* Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening
* Are receiving oral loop diuretics
* Have a left ventricular ejection fraction (LVEF) \< 30% measured within the prior 6 months
* Are currently hospitalized with the primary reason of HF, or had an HF event within 6 months prior to screening
* Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
* Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 mmHg
* Have elevated natriuretic peptide levels (B-type natriuretic peptide \[BNP\] or N-terminal prohormone of B-type natriuretic peptide \[NT-proBNP\]) at screening:
1. Patients without AFF on the screening electrocardiogram (ECG): BNP ≥ 300 pg/mL or NT-proBNP ≥ 1,000 pg/mL
2. Patients with AFF on the screening ECG: BNP ≥ 900 pg/mL or NT-proBNP ≥ 3,000 pg/mL

* Have AFF on the screening ECG and are currently taking digoxin
* Have had acute coronary syndrome, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization therapy within 3 months of screening
* Are admitted to a long-term care facility or hospice
* Have a projected survival of \< 12 months due to non-cardiovascular causes based on clinical judgment
* Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening
* Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening
* Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening
* Have an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 or receiving dialysis at screening
* Have previously had a solid organ transplant
* Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening
* Have previously received omecamtiv mecarbil
* Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP

Contacts and Locations

Study Contact

Cytokinetics MD

CONTACT

(650) 624-2929

medicalaffairs@cytokinetics.com

Principal Investigator

Cytokinetics MD

STUDY_DIRECTOR

Cytokinetics

Study Locations (Sites)

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011

United States

Collaborators and Investigators

Sponsor: Cytokinetics

Cytokinetics MD, STUDY_DIRECTOR, Cytokinetics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-12

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

CK-1827452
omecamtiv mecarbil

Additional Relevant MeSH Terms

Heart Failure
Heart Failure With Reduced Ejection Fraction