StudyFinder
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction (COMET-HF)
Status: Recruiting
A new study called COMET-HF (sponsored by Cytokinetics, Inc.) is looking to see whether a study medicine called omecamtiv mecarbil can lower the risk for heart failure-related events and deaths, heart transplant, and strokes in people who have heart failure with a low ejection fraction (when the heart isn?t pumping out as much blood as it should with each beat).
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
This trial enrolls adults (18?85) with long-standing heart failure with a weak heart pumping function who are already on regular water-pill (diuretic) treatment.
They must also have recently gotten sicker from their heart failure ? either currently hospitalized for it, had a qualifying flare-up in the past year, or needed a notable increase in their diuretic medication at home due to worsening symptoms.
The heart function test must be fairly recent and not skewed by a procedure that could have temporarily boosted it.
Exclusion Criteria:
Patients can?t join the study if they:
? Have irregular heartbeat (AFib) and take digoxin
? Had a heart attack, unstable chest pain, or heart surgery/procedures in the last 3 months
? Live in a nursing home or hospice
? Are expected to live less than a year from a non-heart illness (like cancer)
? Recently needed strong IV heart/blood pressure support medications (within 3 days)Interventions:
Drug/Device: OMECAMTIV MECARBIL
Conditions:
Heart failure with reduced ejection fraction and established on guidelines directed medical therapy.
Keywords:
Heart failure
Contact(s): Zack Malouf - Zmalouf1@hfhs.org
Principal Investigator: Bashar Hannawi
Principal Investigator ID: bhannaw1@hfhs.org
Phase: III
See this study on ClinicalTrials.gov