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 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT04573166
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years;
2. Symptomatic heart failure in NYHA class III or IV ambulatory;
3. Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months;
4. LVEF ≥ 45%;
5. Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest;
6. LVEDP or PCWP-Mean right atrial pressure (MRAP) ≥ 5 mmHg;
7. Systolic blood pressure ≥ 90 mmHg.
Exclusion Criteria:
1. Acute infection or sepsis;
2. Intra-cardiac mass, thrombus or vegetation;
3. Evidence of right heart failure (TAPSE \< 14 mm);
4. Pulmonary hypertension (PASP \> 60 mmHg);
5. Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest;
6. TIA or stroke within the last 6 months;
7. Thromboembolic events within the last 6 months;
8. Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure;
9. Valvular diseases requiring therapy according to current ESC guidelines;
10. Life expectancy \< 1 year for non-cardiovascular reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT04573166
Study Brief:
Protocol Section:
NCT04573166