Using omecamtiv mecarbil to treat chronic heart failure with severely reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of omecamtiv mecarbil, an investigational drug, in patients with chronic heart failure and severely reduced ejection fraction. Participants will be randomized to receive either the drug or a placebo, and the study aims to determine if the treatment can reduce the risk of cardiovascular death, heart failure events, or the need for heart transplantation. The study will conclude when a specified number of participants experience a heart failure event or cardiovascular death, with an interim analysis planned for efficacy and futility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult patients who meet all the following criteria at screening may be included in the study:

* 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 on a regular schedule
* Patients without AFF on screening ECG:

  * LVEF \< 30% within 6 months of screening
  * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL)
* Patients with AFF on screening ECG:

  * LVEF \< 25% within 6 months of screening
  * Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL)
  * Not currently taking digoxin
* Meet one of the following criteria for a recent HF event:

  * Are currently hospitalized with the primary reason of HF
  * Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide Or
  * Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic-equivalent dose; (2) the addition of a new diuretic class to a loop diuretic.
* Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
* Systolic blood pressure ≤ 140 mmHg

Exclusion Criteria:

Any of the following criteria will exclude potential patients from the study:

* Have AFF on the screening ECG and are currently taking digoxin
* Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome and/or any coronary revascularization, cardiac surgery, valve surgery, any coronary revascularization, and/or cardiac resynchronization, or cardiac contractility modulation 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 (except for nocturnal supplemental oxygen for sleep apnea or heart failure)
* 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 received omecamtiv mecarbil in a previous clinical trial
* 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
* Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease

Where it's running

• Advanced Cardiovascular, LLC
  Alexander City, Alabama, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• National Heart Institute
  Beverly Hills, California, United States Recruiting
• UC San Diego Health - Sulpizio Cardiovascular Center
  La Jolla, California, United States Recruiting
• Nutrition Research Center (SPH)
  Loma Linda, California, United States Recruiting
• Keck Medical Center of USC (outpatient clinic)
  Los Angeles, California, United States Recruiting

+163 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Cytokinetics MD
• Email: medicalaffairs@cytokinetics.com
• Phone: (650) 624-2929

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.