Status:
RECRUITING
Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF.
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
InCor Heart Institute
Conditions:
Chagas Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chagas disease is considered by the World Health Organization (WHO) as one of the most neglected tropical diseases in the world, having relevance in many Latin America countries. In addition, it alrea...
Detailed Description
Introduction: Chagas disease (CD) is an infectious parasitic disease caused by the protozoan Trypanosoma cruzi. It is considered by the World Health Organization (WHO) as one of the most neglected tro...
Eligibility Criteria
Inclusion
- Positive serology for Chagas;
- Age \> 18 years old;
- New York Heart Association (NYHA) heart failure and functional class II, III or IV;
- Left ventricular ejection fraction \<40% at least in the last 3 months;
- Patients using a beta-blocker with stable dose (last 4 weeks) and optimized;
- Patients using ACEI or ARB with a stable dose (last 4 weeks) and optimized.
Exclusion
- Participants who do not agree to participate in the study
- Participants who do not want to receive sacubitril/ valsartan medication;
- Patients with symptomatic hypotension;
- Patients with systolic blood pressure (SBP) lower than 95 mmHg on randomization;
- Patients with creatinine clearance (ClCr) less than 30 mL/min;
- Patients with serum potassium \> 5.2 mmol/L;
- Patients with a history of angioedema or who experienced severe side effects with ACE inhibitors.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04853758
Start Date
May 6 2021
End Date
December 1 2024
Last Update
April 4 2024
Active Locations (1)
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1
Heart Institute (Incor) University of Sao Paulo
São Paulo, Brazil, 05403000