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Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study.

Publication ,  Journal Article
Felker, GM; Solomon, SD; McMurray, JJV; Cleland, JGF; Abbasi, SA; Malik, FI; Zhang, H; Globe, G; Teerlink, JR; COSMIC-HF Investigators,
Published in: Circ Heart Fail
December 2020

BACKGROUND: Chronic heart failure with reduced ejection fraction impairs health-related quality of life (HRQL). Omecamtiv mecarbil (OM)-a novel activator of cardiac myosin-improves left ventricular systolic function and remodeling and reduces natriuretic peptides. We sought to evaluate the effect of OM on symptoms and HRQL in patients with chronic heart failure with reduced ejection fraction and elevated natriuretic peptides enrolled in the COSMIC-HF trial (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). 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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Published In

Circ Heart Fail

DOI

EISSN

1941-3297

Publication Date

December 2020

Volume

13

Issue

12

Start / End Page

e007814

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Urea
  • Surveys and Questionnaires
  • Stroke Volume
  • Severity of Illness Index
  • Quality of Life
  • Patient Reported Outcome Measures
  • Middle Aged
  • Male
  • Humans
 

Citation

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Felker, G. M., Solomon, S. D., McMurray, J. J. V., Cleland, J. G. F., Abbasi, S. A., Malik, F. I., … COSMIC-HF Investigators, . (2020). Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study. Circ Heart Fail, 13(12), e007814. https://doi.org/10.1161/CIRCHEARTFAILURE.120.007814
Felker, G Michael, Scott D. Solomon, John J. V. McMurray, John G. F. Cleland, Siddique A. Abbasi, Fady I. Malik, Hanze Zhang, Gary Globe, John R. Teerlink, and John R. COSMIC-HF Investigators. “Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study.Circ Heart Fail 13, no. 12 (December 2020): e007814. https://doi.org/10.1161/CIRCHEARTFAILURE.120.007814.
Felker GM, Solomon SD, McMurray JJV, Cleland JGF, Abbasi SA, Malik FI, et al. Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study. Circ Heart Fail. 2020 Dec;13(12):e007814.
Felker, G. Michael, et al. “Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study.Circ Heart Fail, vol. 13, no. 12, Dec. 2020, p. e007814. Pubmed, doi:10.1161/CIRCHEARTFAILURE.120.007814.
Felker GM, Solomon SD, McMurray JJV, Cleland JGF, Abbasi SA, Malik FI, Zhang H, Globe G, Teerlink JR, COSMIC-HF Investigators. Effects of Omecamtiv Mecarbil on Symptoms and Health-Related Quality of Life in Patients With Chronic Heart Failure: Results From the COSMIC-HF Study. Circ Heart Fail. 2020 Dec;13(12):e007814.

Published In

Circ Heart Fail

DOI

EISSN

1941-3297

Publication Date

December 2020

Volume

13

Issue

12

Start / End Page

e007814

Location

United States

Related Subject Headings

  • Ventricular Dysfunction, Left
  • Urea
  • Surveys and Questionnaires
  • Stroke Volume
  • Severity of Illness Index
  • Quality of Life
  • Patient Reported Outcome Measures
  • Middle Aged
  • Male
  • Humans