NCT06704633RecruitingPhase 4
Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania
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
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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®.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 298 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Martin Rohacek
- Diseases
- Heart failure
- NCT number
- NCT06704633
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 298
- From 30 Jun 2026 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unacceptable side effects prior during receipt of ACE inhibitors or ARBs
Other illness
- History of angioedema
Lab values
- 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
Other
- Pregnancy
- Systolic blood pressure of less than 95 mmHg,
- Inability to sign an informed consent form.
Who the study is looking for
- 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%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Heart and Lung Clinic, St Francis Regional Referral Hospital, Ifakara, Tanzania Coordinator of this site? Confirm its status | Ifakara | Tanzania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.