A Double-blind Randomized Placebo-controlled Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects with Heart Failure with Reduced Ejection Fraction and Decreased Exercise Tolerance | NYU Langone Health

A Double-blind Randomized Placebo-controlled Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects with Heart Failure with Reduced Ejection Fraction and Decreased Exercise Tolerance

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Heart Failure
Age: Between 18 years - 85 years
Gender: Male or Female

Other Inclusion Criteria:
1. Participant provided written informed consent
2. History of chronic HF, defined as requiring continuous treatment with medications for HF for a minimum of 3 months before screening
3. New York Heart Association (NYHA) class II or III at screening
4. Left ventricular ejection fraction (LVEF) = 35%, per subject’s most recent medical record or an echocardiogram at screening
5. Participants must satisfy all Screening assessments

You may not be eligible for this study if the following are true:

1. Severe uncorrected valvular heart disease
2. Paroxysmal atrial fibrillation or flutter
3. Untreated severe ventricular arrhythmias
4. Symptomatic bradycardia, second-degree Mobitz type II, or third-degree heart block without a pacemaker
5. Recipient of a major organ transplant or ventricular assist device, or anticipated transplantation or chronic mechanical circulatory support
6. Malignancy
7. Known sensitivity to any of the products or components
8. History of gastrointestinal bleeding requiring hospitalization, urgent procedure or transfusion in the prior year
9. Ongoing or planned enrollment in cardiac rehabilitation
10. Requires assistance to walk or use of mobility assistive devices
11. Clinically significant comorbid disease, disorder, condition or behavioral or other limitation that, in the opinion of the investigator or medical monitor, if consulted, is expected to:
  - Reduce life expectancy to < 2 years
  - Pose a risk to subject safety by participating in the study
  - Substantially limit exercise testing
  - Interfere with study evaluation, procedures, compliance (including study medication and procedures) or completion
12. Major medical event or procedure within 3 months prior to randomization
13. Scheduled major surgery or procedure in the next 6 months.
14. Currently participating in another investigational device or drug study
15. Pregnant or breastfeeding
16. Participants of childbearing potential not willing to use protocol accepted birth control