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New treatment option for Heart Failure
Official title Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
ClinicalTrials.gov ID: NCT06736574
What this study is testing
What is Omecamtiv Mecarbil (OM)?
Omecamtiv Mecarbil (OM) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- Are established on regional standard-of-care HF therapies for at least 30 days prior to screening
- Systolic blood pressure ≤ 140 mmHg
- 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...
- 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
- Alexander City, Alabama, United States
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Clara, California, United States
- Stanford, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Bridgeport, Connecticut, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Clearwater, Florida, United States
- Fort Lauderdale, Florida, United States
+ 155 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alexander City, Alabama, United States; Birmingham, Alabama, United States; Tucson, Arizona, United States; Beverly Hills, California, United States; La Jolla, California, United States; Loma Linda, California, United States and 169 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.