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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT03288194
Eligibility Criteria:
Inclusion Criteria:
* Outpatient
* Age \> 21
* Exhibits symptoms of hear failure (NYHA Class II or III)
* Left ventricular ejection fraction (LVEF) \>= 40%
* Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score \< 60
Exclusion Criteria:
* Cannot speak English
* Lack telephone access
* Unwilling to be randomized, or
* Unavailable for the study period
* Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
* Planned (within 6 months) cardiac surgery
* Cognitive impairment indicative of dementia
* Recent (3 months)
* acute myocardial infarction,
* cardiac decompensation, or
* HF-related hospitalization.
* Use intravenous inotropic medication
* Use an assistive circulatory device
* Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)
* Currently receiving mental health counseling;
* A history of:
* bipolar disorder,
* psychosis, or
* substance abuse/dependency
* Severe depressive symptoms or suicidality
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT03288194
Study Brief:
Protocol Section:
NCT03288194