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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07326605
Eligibility Criteria:
Inclusion Criteria:
1. Symptoms and/or signs of HF ≥ New York Heart Association (NYHA) class II;
2. Left ventricular ejection fraction (LVEF) of 50% or higher;
3. N-terminal fragment of the prohormone of brain natriuretic peptide (NT-proBNP) level \> 125 pg/mL or brain natriuretic peptide (BNP) level \> 35 pg/mL in sinus rhythm, or NT-proBNP level \> 365 pg/mL or BNP level \> 105 pg/mL in atrial fibrillation;
4. At least one of objective indicators of (i) cardiac structural abnormalities including LA maximum volume index (LAVi max) \> 29 mL/m2 or echocardiography-measured LV end-diastolic mass index (LVMi) ≥ 115 g/m2 for men and ≥ 95 g/m2 for women, and (ii) LV diastolic dysfunction including early and/or late diastolic mitral inflow velocity (E/A) \< 1 or early diastolic mitral inflow velocity and/or mitral annular peak early diastolic velocity (E/e') \> 13.
Exclusion Criteria:
1. Primary cardiomyopathy;
2. Acute coronary syndrome;
3. Primary severe valvular heart disease;
4. Acute pulmonary embolism;
5. Severe renal dysfunction;
6. Poor image quality that was insufficient to identify myocardial endocardium and epicardium.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07326605
Study Brief:
Protocol Section:
NCT07326605