Evaluating Sacubitril-Valsartan Treatment in Adults with Heart Failure and Reduced Ejection Fraction in Rural Tanzania

What this Trial Is About

Researchers are evaluating the effect of switching from angiotensin converting enzyme ACE inhibitors or angiotensin receptor blockers ARB to angiotensin-neprilysin inhibitors ARNI in adults with symptomatic heart failure with reduced ejection fraction HFrEF in rural Tanzania. Heart failure is a significant health issue in sub-Saharan Africa, with high mortality rates, and this study aims to assess the health status benefits and safety of sacubitrilvalsartan ARNI in this population where it has not been previously studied except in South Africa. Participants who have been on stable heart failure treatment with ACE inhibitors or ARBs, beta-blockers, and spironolactone for at least 3 months will switch to sacubitrilvalsartan after a 36-hour washout of ACE inhibitors. The dose will start at 50 mg twice daily for two weeks, increase to 100 mg twice daily for three weeks, and then to 200 mg twice daily. Beta blockers and spironolactone will continue, with diuretics adjusted as needed. The study period includes 10 months of follow-up with scheduled visits for assessments and medication adherence. During the study, participants will undergo baseline and follow-up evaluations including physical exams, questionnaires measuring health status Kansas City Cardiomyopathy Questionnaire, 6-minute walking tests, echocardiography, blood tests for biomarkers like brain natriuretic peptide BNP, and monitoring of vital signs. Medication adherence will be tracked by pill count and self-report. Safety and efficacy outcomes, including quality of life improvements, heart function, and hospitalization rates, will be measured over 10 months. Sacubitrilvalsartan will be provided free during the study, and transport costs for visits will be reimbursed.

Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania