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:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT02152566
Eligibility Criteria:
Inclusion Criteria:
* Men and Women aged ≥ 18 years
* Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months
* Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit.
* New York Heart Association Class II or III after optimization of medical therapy
* Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry
Exclusion Criteria:
* Unstable angina
* Myocardial infarction within the last 12 months
* Cardiac surgery within the previous 6 months
* Pregnancy
* Unwilling or unable to provide informed consent
* Uncontrolled arrhythmias
* Severe valvular heart disease
* Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02152566
Study Brief:
Protocol Section:
NCT02152566