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 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT04154657
Eligibility Criteria:
Inclusion criteria:
Diagnosis of HFpEF as follows
* Heart failure NYHA II or NYHA III
* LVEF ≥ 50%
* HFA-PEFF score ≥ 5 OR HFA-PEFF score 2-4 with one of the following criteria:
* baseline PCWP ≥ 15 mm Hg OR PCWP increase ≥ 10 mm Hg with exercise (\~20 Watt)
* stable medical therapy for last 4 weeks
Exclusion criteria:
* Significant coronary stenosis \> 50% or valvular heart disease requiring intervention
* coronary or cardiac valvular intervention \< 3 months
* uncontrolled rate of atrial fibrillation
* Severe chronic kidney disease (MDRD eGFR \< 30 ml/min)
* Life expectancy \< 12 months
* Contraindication to MRI or other planned investigations
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04154657
Study Brief:
Protocol Section:
NCT04154657