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:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT04853758
Eligibility Criteria:
Inclusion Criteria:
1. Positive serology for Chagas;
2. Age \> 18 years old;
3. New York Heart Association (NYHA) heart failure and functional class II, III or IV;
4. Left ventricular ejection fraction \<40% at least in the last 3 months;
5. Patients using a beta-blocker with stable dose (last 4 weeks) and optimized;
6. Patients using ACEI or ARB with a stable dose (last 4 weeks) and optimized.
Exclusion Criteria:
1. Participants who do not agree to participate in the study
2. Participants who do not want to receive sacubitril/ valsartan medication;
3. Patients with symptomatic hypotension;
4. Patients with systolic blood pressure (SBP) lower than 95 mmHg on randomization;
5. Patients with creatinine clearance (ClCr) less than 30 mL/min;
6. Patients with serum potassium \> 5.2 mmol/L;
7. Patients with a history of angioedema or who experienced severe side effects with ACE inhibitors.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04853758
Study Brief:
Protocol Section:
NCT04853758