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Taking people in TanzaniaPhase 4

Tests sacubitril-valsartan in people with heart failure in rural Tanzania

Switches heart failure patients from ACE inhibitors or ARBs to sacubitril-valsartan, then checks health status.

Plain-language title generated from the registry record
Registry title: Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania

Key facts

Where
Ifakara, TanzaniaSee the site
Phase
Phase 4

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure and a weak heart pump who still have symptoms despite regular heart failure treatment. They will be switched to sacubitril/valsartan.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Heart failure with symptoms (NYHA class II-IV) and a left ventricular ejection fraction (LVEF) of 40% or lower.
Earlier treatment
At least 3 months of an ACE inhibitor or an ARB, a beta-blocker and spironolactone in recommended doses, with at least 80% adherence.

Main reasons for not taking part

  • Pregnancy
  • Systolic blood pressure below 95 mmHg
  • eGFR below 30 ml per minute per 1.73 m2 of body-surface area
  • Serum potassium above 5.4 mmol per liter
  • History of angioedema

Read by machine on 11 November 2026.

Where in Tanzania

  • Heart and Lung Clinic, St Francis Regional Referral Hospital, Ifakara, TanzaniaIfakara, TanzaniaContact: Samuel S Mutasingwa, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Martin Rohacek
Trial code
NCT06704633
Record updated
2 July 2026
Original 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 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®.Read full original descriptionShow less

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

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®.

Inclusion: 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: Unacceptable side effects prior during receipt of ACE inhibitors or ARBs; History of angioedema; 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; Pregnancy; Systolic blood pressure of less than 95 mmHg,; Inability to sign an informed consent form.

ClinicalTrials.gov NCT06704633