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NCT06704633 · ClinicalTrials.gov record · last posted 2026-07-02

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

StatusRecruiting
PhasePhase 4
Started2026-06-30
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
Angiotensin-neprilysin inhibitors (ARNI) are beneficial in patients with heart failure with reduced ejection fraction. No study evaluating ARNI has been conducted in sub-Saharan Africa (except South Africa) yet, where heart failure is a major health problem. Before implementing ARNI in Tanzania, a study evaluating the benefit and safety of ARNI in Africans is needed. The aim of this interventional pre-post study is to evaluate the health status of symptomatic patients with heart failure with reduced ejection fraction who are under a chronic heart failure therapy, before and after switching angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) to ARNI. Participants will be recruited at the Heart and Lung Clinic of the St Francis Regional Referral Hospital in Ifakara in rural Tanzania during a study period of 30 months, including 10 months of follow-up. A total of 298 participants will be included. The investigators hypothesize that health status, expressed by the Kansas City Cardiomyopathy Questionnaire summary score and 6-minute walking test, will improve after switching from ACE-inhibitors or ARB to ARNI. In Tanzania, sacubitril/valsartan is registered under the name Uperio®.

Protocol amendment history 3 changes detected by DataLookout

2026-07-03
notable
Recruitment opened
2026-07-03
notable
Primary completion pushed: 2028-10-30 → 2028-11-30
2026-07-03
minor
Completion pushed: 2028-10-30 → 2028-11-30
Trial Details
NCT Number NCT06704633
Lead Sponsor Martin Rohacek
Collaborators: Ifakara Health Institute (IHI)
Conditions Heart Failure
Enrollment 298 participants
Start Date 2026-06-30
Primary Completion 2028-11-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-02