Switching to sacubitril-valsartan in heart failure with reduced ejection fraction in rural Tanzania
Official title: Health Status After Switching Angiotensin-converting Enzyme Inhibitors or Angiotensin Receptor Blockers to Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania: An Interventional Study
Run by Swiss Tropical & Public Health Institute · NCT06704633 · Data updated 2026-11-12
This study tests whether swapping ACE inhibitors or ARBs for sacubitril-valsartan improves health status in adults with heart failure and reduced ejection fraction in rural Tanzania.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 298 (estimated) |
| Sponsor | Swiss Tropical & Public Health Institute Academic / other |
| Locations | 1 site (Ifakara, Morogoro) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | November 30, 2028 |
| Study ends | November 30, 2028 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT06704633 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptomatic heart failure (NYHA II-IV) and LVEF ≤40% who are on ACE inhibitors or ARBs, beta-blockers, and spironolactone at guideline-based doses for at least 3 months with adherence ≥80%.
✕Probably not a fit
Patients with very low blood pressure, significant kidney dysfunction, high potassium, history of angioedema, or intolerance to prior ACE/ARB therapy may not benefit and could be excluded for safety reasons.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 4 interventional study will enroll up to 298 adults with symptomatic heart failure and LVEF ≤40% who are already on guideline-directed therapy and switch them from an ACE inhibitor or ARB to sacubitril-valsartan. Participants will be followed for up to 10 months after the switch to assess changes in health status and safety. The study is conducted at the Heart and Lung Clinic of St Francis Regional Referral Hospital in Ifakara, Tanzania, and aims to generate local evidence on the benefits and safety of ARNI therapy in sub-Saharan Africa. The design is pre-post, comparing health status before and after the switch within the same individuals. Primary outcomes focus on patient-reported health status, with safety monitoring throughout the follow-up period.
Why it matters
Potential benefit: If successful, patients may experience improved symptoms and quality of life after switching to sacubitril-valsartan.
How similar studies have gone: Prior ARNI trials in other regions showed benefits; this study explores applicability in a sub-Saharan African population and provides local safety and efficacy data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Symptomatic heart failure NYHA class II-IV and * Left ventricular ejection fraction (LVEF) ≤40% and * Treatment with an ACE Inhibitor or an ARB, beta-blocker, and spironolactone in recommended dosages for at least 3 months, and * Adherence to this therapy of at least 80%. Exclusion criteria * Pregnancy * Systolic blood pressure of less than 95 mmHg, * eGFR below 30 ml per minute per 1.73 m2 of body-surface area * Serum potassium level of more than 5.4 mmol per liter * History of angioedema * Unacceptable side effects prior during receipt of ACE inhibitors or ARBs * Inability to sign an informed consent form.
Where it's running
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Heart and Lung Clinic, St Francis Regional Referral Hospital, Ifakara, Tanzania
Ifakara, Morogoro, Tanzania Recruiting
Study contacts
- Principal investigator: Samuel S Mutasingwa, MD — Ifakara Health Iistitute
- Study coordinator: Martin Rohacek, PD Dr med
- Email: mrohacek@ihi.or.tz
- Phone: +255625064252
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.