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Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

Research area:
Heart Failure
Principal investigator:
Susan Joseph, MD
Type of study:
Interventional

Study synopsis:
The purpose of this study is to determine if treatment with omecamtiv mecarbil/AMG 423 when added to standard of care is well tolerated and superior to a placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF..

Study objective:
The study will evaluate several outcomes measures including:

  • Evaluate the effect of omecamtiv mecarbil/AMG 423 as compared with a placebo in subjects with chronic heart failure with reduced ejection fraction receiving standard of care therapy
  • Measure changes in patient reported outcomes Kansas City Cardiomyopathy Questionnaire total symptom score to evaluate effect of treatment with omecamtiv mecarbil/AMG 423 on changes in patient reported outcomes
  • Evaluate effects of omecamtiv mecarbil/AMG 423 to first heart failure hospitalization
  • Evaluate effects of omecamtiv mecarbil/AMG 423 to all-cause death
  • Evaluate safety of oecamtiv mecarbil/AMG 423 by measuring incidence of reported adverse events, incidence of reported serious adverse events of ventricular arrhythmias requiring treatment
  • Measure incidence of positively adjudicated major cardiac ischemic events

Main/critical inclusion and exclusion criteria:
A complete list of inclusion and exclusion criteria can be found at: https://www.clinicaltrials.gov/ct2/show/NCT02929329?term=GALACTIC-HF&rank=1
Study contact:
Taylor Poyner, BSN, RN, taylor.poyner@bswhealth.org.


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