Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT02695420
Eligibility Criteria:
Inclusion Criteria:
* Japanese male or female ≥ 20 years and ≤ 85 years of age
* History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
* Treated for HF with optimal pharmacological therapy
* Left ventricular ejection fraction ≤ 40% at screening
Exclusion Criteria:
* Severe uncorrected valvular heart disease
* Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
* Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization
* Systolic blood pressure (BP) \> 160 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg, or heart rate (HR) \> 110 beats per minute (bpm) or HR \< 50 bpm
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
* Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT02695420
Study Brief:
Protocol Section:
NCT02695420