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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02600234
Eligibility Criteria:
Key Inclusion Criteria:
* Chronic symptomatic Heart Failure
* Ongoing stable GDMT HF management and management of potential comorbidities
* Age ≥ 40 years old
* LV ejection fraction ≥ 40% within the past 3 months, without previously documented ejection fraction \<30%.
* Elevated left atrial pressure with a gradient compared to right atrial pressure (RAP) documented by end-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than RAP by ≥ 5 mm Hg
Key Exclusion Criteria:
* MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization
* Cardiac Resynchronization Therapy initiated within the past 6 months
* Severe heart failure
* Inability to perform 6 minute walk test (distance \< 50 m), OR 6 minute walk test \> 600m
* History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
* Presence of significant valve disease
* Known clinically significant untreated carotid artery stenosis
* Currently requiring dialysis; or estimated-GFR \<25ml/min/1.73 m2 by CKD-Epi equation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02600234
Study Brief:
Protocol Section:
NCT02600234