Phase
Condition
Congestive Heart Failure
Heart Failure
Hyponatremia
Treatment
Placebo
Omecamtiv Mecarbil (OM)
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 minimumof 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) ≥ 1000pg/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) ≥ 3000pg/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 priorto screening
Systolic blood pressure ≤ 130 mmHg and diastolic blood pressure ≤ 90 mmHg
Exclusion
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 coronaryrevascularization, and/or cardiac resynchronization therapy within 3 months ofscreening
Are admitted to a long-term care facility or hospice
Have a projected survival of < 12 months due to non-cardiovascular causes based onclinical judgment
Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior toscreening
Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 daysprior to screening
Are receiving intravenous diuretics, intravenous vasodilators, or supplementaloxygen therapy ≤ 12 hours prior to screening
Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receivingdialysis at screening
Have previously had a solid organ transplant
Are receiving treatment in another investigational device or drug study or arewithin 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 tobreastfeed during treatment with IP or within 5 days after the end of treatment withIP
Study Design
Study Description
Connect with a study center
Advanced Cardiovascular, LLC
Alexander City, Alabama 35010
United StatesActive - Recruiting
San Diego Cardiac Center
San Diego, California 92123
United StatesActive - Recruiting
CHF Heart Clinical (Subject Visits & IP Shipments)
Clearwater, Florida 33756
United StatesActive - Recruiting
South Florida Research Solutions, LLC
Hollywood, Florida 33351
United StatesActive - Recruiting
Broward Research Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Ocala Cardiovascular Research
Ocala, Florida 34471
United StatesActive - Recruiting
Cardiovascular Research of Northwest Indiana, LLC.
Munster, Indiana 46321
United StatesActive - Recruiting
Reid Physician Associates
Richmond, Indiana 47374
United StatesActive - Recruiting
The University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
United StatesActive - Recruiting
Advanced Heart Care, LLC
Bridgewater, New Jersey 08807
United StatesActive - Recruiting
Montefiore Medical Center (Moses Campus)
Bronx, New York 10467
United StatesActive - Recruiting
Moses H. Cone Memorial Hospital Operating Corporation d/b/a Cone Health
Greensboro, North Carolina 27401
United StatesActive - Recruiting
K&R Research LLC
Marion, Ohio 43302
United StatesActive - Recruiting
Capital Area Research, LLC
Camp Hill, Pennsylvania 17011
United StatesActive - Recruiting
Monument Health Clinical Research, a department of Monument Health Rapid City Hospital, Inc.
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Tennessee Center for Clinical Trials
Tullahoma, Tennessee 37388
United StatesActive - Recruiting
Medresearch Inc
El Paso, Texas 79902
United StatesActive - Recruiting
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