RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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)

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

Condition
Heart Failure
Intervention / Treatment

-

Contacts and Locations

Camp Hill

Capital Area Research, LLC, Camp Hill, Pennsylvania, United States, 17011

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cytokinetics,

Cytokinetics MD, STUDY_DIRECTOR, Cytokinetics

Study Record Dates

2027-12