Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Omecamtiv Mecarbil; Placebo; Standard of Care
Intervention description: Omecamtiv mecarbil tablets for oral administration; Matching placebo tablets; Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8256.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to
      standard of care is well tolerated and superior to placebo in reducing the risk of
      cardiovascular death or heart failure events in adults with chronic heart failure with
      reduced ejection fraction (HFrEF).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject has provided informed consent

          -  Male or female, ≥ 18 to ≤ 85 years

          -  History of chronic heart failure (HF), defined as requiring treatment for HF for a
             minimum of 30 days before randomization

          -  Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical
             record, within 12 months prior to screening.

          -  New York Heart Association (NYHA) class II to IV at most recent screening assessment.

          -  Managed with HF standard of care (SoC) therapies consistent with regional clinical
             practice guidelines according to investigator judgment of subject's clinical status

          -  Current hospitalization with primary reason of HF OR one of the following events
             within 1 year of screening: hospitalization with primary reason of HF; urgent visit to
             emergency department (ED) with primary reason of HF.

          -  Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic
             peptide (NT-proBNP)

        Other Inclusion Criteria May apply

        Key Exclusion Criteria:

          -  Currently receiving treatment in another investigational device or drug study, or < 30
             days since ending treatment on another investigational device or drug study(ies).
             Other investigational procedures while participating in this study are excluded.

          -  Malignancy within 5 years prior to randomization with the following exceptions:
             localized basal or squamous cell carcinoma of the skin, cervical intraepithelial
             neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.

          -  Subject has known sensitivity to any of the products or components to be administered
             during testing

        Other Exclusion Criteria May apply