Angiotensin receptor-Neprilysin inhibition in chagasics cardiomyopathy with reduced ejection fraction: randomized trial ANSWER-HF

• Grant number: 20/06252-5
• Support Opportunities: Regular Research Grants
• Start date: February 01, 2021
• End date: April 30, 2025
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Felix José Alvarez Ramires
• Grantee: Felix José Alvarez Ramires
• Host Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Barbara Maria Ianni ; Charles Mady ; Fabio Fernandes ; Fernanda Gallinaro Pessoa ; Keila Cardoso Barbosa ; Orlando do Nascimento Ribeiro ; Paula de Cássia Buck ; Paulo Vinicius Ramos Souza ; Vagner Madrini Junior

Abstract

Chagas' disease is a parasitic infection caused by the protozoan Trypanosoma cruzi (T. cruzi). It is considered by the World Health Organization (WHO) as one of the 13 most neglected diseases in the world. Chagas cardiomyopathy is associated with significant heart failure, sudden death, often due to severe arrhythmias; and thromboembolic phenomena, whether peripheral or central. The PARADIGM-HF study brought to a new class of drugs, INRAS (Neprilysin Inhibitor and Angiotensin Receptors), with sacubitril/valsartan being the first molecule to show benefit in hospitalization and mortality in patients with heart failure. This study included 113 patients with Chagas disease, therefore, with no statistic power. The project in question will be a prospective, double-blind, randomized, controlled trial. Will be included 200 participants, randomized independently at the Instituto do Coração da Faculdade de Medicina da Universidade de São Paulo (InCor). This project can evaluate the benefit of sacubitril/valsartan compared to enalapril in patients with chagasic heart failure with reduced ejection fraction (LVEF <40%). After 6-month follow-up of these patients, will be evaluated, an improvement in ejection fraction, improvement in functional class, reduction in ventricular arrhythmias, hospitalization for heart failure and all causes mortality. (AU)