Abstract | BACKGROUND: METHODS: Patients (n=448) were randomized 1:1:1 to placebo, 25 mg of OM BID, or to pharmacokinetically guided dose titration (OM-PK) for 20 weeks. The Kansas City Cardiomyopathy Questionnaire was administered to assess HRQL at baseline, 16 weeks, and 20 weeks. The primary scores of interest were the Total Symptom Score, Physical Limitation Scale, and Clinical Summary Score. RESULTS: Mean change in score from baseline to 20 weeks for the Total Symptom Score was 5.0 (95% CI, 1.8-8.1) for placebo, 6.6 (95% CI, 3.4-9.8) for OM 25 mg (P=0.32 versus placebo), and 9.9 (95% CI, 6.7-13.0) for OM-PK (P=0.03 versus placebo); for the Physical Limitation Scale, it was 3.1 for placebo (95% CI, -0.3 to 6.6), 6.0 (95% CI, 3.1-8.9) for OM 25 mg (P=0.12), and 4.3 (95% CI, 0.7-7.9) for OM-PK (P=0.42); for the Clinical Summary Score, it was 4.1 (95% CI, 1.4-6.9) for placebo, 6.3 (95% CI, 3.6-9.0) for OM 25 mg (P=0.19), and 7.0 (95% CI, 4.1-10.0) for OM-PK (P=0.14). Differences between OM and placebo were greater in patients who were more symptomatic at baseline. CONCLUSIONS: HRQL as measured by the Total Symptom Score improved in patients with heart failure with reduced ejection fraction assigned to the OM-PK group relative to placebo. Ongoing trials are prospectively testing whether OM improves symptoms and HRQL in heart failure with reduced ejection fraction. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01786512.
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Authors | G Michael Felker, Scott D Solomon, John J V McMurray, John G F Cleland, Siddique A Abbasi, Fady I Malik, Hanze Zhang, Gary Globe, John R Teerlink, COSMIC-HF Investigators |
Journal | Circulation. Heart failure
(Circ Heart Fail)
Vol. 13
Issue 12
Pg. e007814
(12 2020)
ISSN: 1941-3297 [Electronic] United States |
PMID | 33176437
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers
- omecamtiv mecarbil
- Urea
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Topics |
- Aged
- Biomarkers
(blood)
- Chronic Disease
- Female
- Heart Failure
(drug therapy)
- Humans
- Male
- Middle Aged
- Patient Reported Outcome Measures
- Quality of Life
- Severity of Illness Index
- Stroke Volume
(drug effects)
- Surveys and Questionnaires
- Urea
(analogs & derivatives, therapeutic use)
- Ventricular Dysfunction, Left
(drug therapy)
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