Phase 3
N=8,232
Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02929329 ↗Enrolled (actual)
8,232
Serious AEs
58.6%
Results posted
Jul 2021
Primary outcome: Primary: Time to Cardiovascular Death or First Heart Failure Event — 39.1; 37.0 percentage of participants — p=0.0252
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omecamtiv Mecarbil (Drug); Placebo (Drug); Standard of Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cytokinetics
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Cardiovascular Death or First Heart Failure Event |
39.1; 37.0 | 0.0252 sig |
| SECONDARY Time to Cardiovascular Death |
19.4; 19.6 | 0.8555 |
| SECONDARY Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24 |
6.29; 5.83; 21.15; 23.65 | 0.0278 sig |
| SECONDARY Time to First Heart Failure Hospitalization |
28.7; 27.7 | 0.1902 |
| SECONDARY Time to All-cause Death |
25.9; 25.9 | 0.9633 |
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
Data sourced from ClinicalTrials.gov (NCT02929329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.