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:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT06785506
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 years or older
* Capable of understanding and signing informed consent
* A diagnosis of HFpEF according to the HFA-PEFF diagnostic algorithm of the ESC or/and a high (90%) probability of HFpEF according to the H2FPEF score, i.e. a score of 6 or higher.
Exclusion Criteria:
* History of LVEF ≤40%
* Scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion
* Impaired renal function, defined as eGFR \< 20 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis at the time of screening
* Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening
* COPD Gold stage IV
* Congenital heart disease
* Pregnancy
* Coexistent condition with life expectancy of \<1 year
* Unlikely to appear at all scheduled follow-up visits
* Linguistic barrier
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06785506
Study Brief:
Protocol Section:
NCT06785506