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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04632160
Eligibility Criteria:
Select Inclusion Criteria:
* Chronic symptomatic heart failure with preserved or mid-range left ventricular ejection fraction (HFpEF or HFrEF)
* Participant is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
Select Exclusion Criteria:
* Myocardial infarction and/or percutaneous cardiac intervention within past 3 months; Coronary artery bypass surgery in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months
* Advanced heart failure
* History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
* Significant heart valve disease
* Chronic pulmonary disease
* Women of childbearing potential
* Severe obstructive sleep apnea not treated with CPAP or other measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04632160
Study Brief:
Protocol Section:
NCT04632160