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

Launched by CYTOKINETICS · Dec 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called omecamtiv mecarbil to see if it can help patients with chronic heart failure who have a severely reduced ability of the heart to pump blood. The goal is to find out if this medication can lower the chances of serious problems like needing to go to the hospital, having a heart transplant, or even dying. The study is currently looking for participants aged 18 to 85 who have been diagnosed with heart failure and have specific heart function measurements indicating a very low ejection fraction, meaning their heart is not pumping well.

To be eligible for this study, participants should have been receiving treatment for heart failure for at least three months, be on certain heart medications, and have had a recent heart-related event or hospitalization. Participants will be monitored closely during the trial and may receive the study drug or a placebo (a non-active treatment) to see how well it works. It's important to note that certain health conditions or treatments may exclude someone from participating. If you're interested or think you might qualify, it's a great opportunity to potentially help improve treatment options for heart failure.

Gender

ALL

Eligibility criteria

• 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
• * 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
• • 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
• 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 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