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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06844032
Eligibility Criteria:
Inclusion Criteria:
1. Signed and data informed consent;
2. New York Heart Association (NYHA) class II-III heart failure;
3. Left ventricular ejection fraction \> 50%;
4. Elevated LV filling pressures assessed by echocardiography at rest or at peak exercise.
Exclusion Criteria:
1. Evidence of myocardial ischemia during stress echocardiography;
2. Significant lesions of the main coronary arteries;
3. Genetic forms of HFpEF (HCM, amyloidosis, Fabry disease, glycogen storage diseases etc.);
4. Peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, viral myocarditis, isolated right-sided HF without left-sided structural disease, constrictive pericarditis, significant pericardial effusion;
5. Significant lung disease (severe lung disease requiring home oxygen or chronic oral steroid therapy);
6. Primary pulmonary artery hypertension;
7. Significant left-sided structural valve disease;
8. Anemia (Hb \< 100 g/L);
9. Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 (CKD-EPI);
10. Non-cardiac conditions that complicate/exclude participation in the study;
11. Exacerbation of heart failure less than 3 months prior to study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06844032
Study Brief:
Protocol Section:
NCT06844032