Using a new heart medication for Chagas cardiomyopathy with reduced ejection fraction
Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: Randomized Trial ANSWER-HF
This study is testing if a new heart medication can help people with Chagas cardiomyopathy and low heart function feel better and lower their chances of serious heart problems compared to standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT04853758 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of sacubitril/valsartan, a combination medication, in treating patients with Chagas cardiomyopathy who have reduced ejection fraction. The study aims to determine if this treatment can improve heart failure symptoms and reduce the risk of cardiovascular death or hospitalization. Participants must have a confirmed diagnosis of Chagas disease and meet specific heart failure criteria. The trial will compare outcomes between those receiving sacubitril/valsartan and those on standard treatment with enalapril.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a positive serology for Chagas disease and heart failure classified as NYHA functional class II, III, or IV.
Not a fit: Patients with symptomatic hypotension or those who have experienced severe side effects from ACE inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with Chagas cardiomyopathy.
How similar studies have performed: Previous studies, such as PARADIGM-HF, have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- Heart Institute (Incor) University of Sao Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Felix José JA Ramires, MD,PhD — Instituto do Coração - INCORHCFMUSP
- Study coordinator: Felix José A Ramires, MD, PhD
- Email: felix.ramires@incor.usp.br
- Phone: 551126615057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.