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Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
EU CTIS ID: 2024-519219-32-00
What this study is testing
To evaluate the efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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 decompensation - 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
You likely can't join if
- 1. •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, 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.