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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT02099903
Eligibility Criteria:
Inclusion Criteria:
1. Patients ≥ 18 to ≤ 70 years of age with chronic systolic heart failure, Chagas disease etiology.
2. Two positive serology results for Chagas by two distinct methods.
3. NYHA (New York Heart Association) class II or III.
4. Patients treated with maximum tolerated doses of standard pharmacotherapy for heart failure.
5. LVEF (Left Ventricular Ejection Fraction) ≤ 40% (Simpson Method).
Exclusion Criteria:
1. Patients with NYHA class I or IV.
2. Sustained ventricular tachycardia (\>30 sec) or with hemodynamic compromise.
3. Presence of permanent pacemaker or implantable defibrillator.
4. Systolic blood pressure \< 90 mmHg.
5. Heart beat \< 60 bpm at rest.
6. Advanced renal insufficiency (estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73 square meters).
7. Patients with planned cardiac surgery or percutaneous revascularization.
8. Other reasons which would preclude the patient from participating in the study (comorbidities, life expectancy less than 1 year).
9. Unsuitable anatomy of renal arteries, renal stenosis or previous treatment with balloon or stent.
10. Refusal of the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02099903
Study Brief:
Protocol Section:
NCT02099903