Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania
Recruiting · NCT06704633 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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®.
Who can take part
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 is running
1 location listed.
- Heart and Lung Clinic, St Francis Regional Referral Hospital, Ifakara, Tanzania - Ifakara, Morogoro, Tanzania