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Sacubitril-valsartan in Patients With Heart Failure With Reduced Ejection Fraction From Rural Tanzania

RecruitingPhase 4Ages 18 Years - anyAllMartin Rohacek
NCT06704633 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 to

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sacubitril / Valsartan Oral Tablet
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Where

1 site
Heart and Lung Clinic, St Francis Regional Referral Hospital, Ifakara, Tanzania
Ifakara, Tanzania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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