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NCT06704633
Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania
Phase 4 trial testing Sacubitril / Valsartan Oral Tablet in Heart Failure in 238 participants. Not yet recruiting.
30 April 2028
Quick facts
| Lead sponsor | Martin Rohacek |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 238 |
| Start date | 5 January 2026 |
| Primary completion | 30 April 2028 |
| Estimated completion | 30 April 2028 |
| Sites | 1 location across Tanzania |
Drugs / interventions tested
- Sacubitril / Valsartan Oral Tablet — full drug profile →
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
Martin Rohacek
Who can join
18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 238 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®.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT06704633
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Related trials
Other trials of Sacubitril / Valsartan Oral Tablet
Trials testing the same drug.
- NCT05117736 — ARNI Versus plAcebo in Patients With Congenital sYStemic Right Ventricle Heart Failure · NA · terminated
- NCT05881720 — Sacubitril/Valsartan Versus Valsartan in Heart Failure · Phase 4 · completed
- NCT04218435 — Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients · completed
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06704633 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Martin Rohacek
- Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06704633.
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