[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570237":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":25,"locations":35,"responsibleParty":54,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":19,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":19,"enrollmentInfo":71,"targetDuration":19,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":38,"whyStopped":19,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Swiss Tropical & Public Health Institute","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Symptomatic adult particiopants with HFrEF, under heart failure therapy","Symptomatic adults with HFrEF, under heart failure medication",[12],"Drug: Sacubitril \u002F Valsartan Oral Tablet",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Sacubitril \u002F Valsartan Oral Tablet","A 36-hour wash-out of ACE inhibitors before initiating ARNI will be done, because of a risk of angioedema if ARNI is started without a wash-out period. The ACE inhibitor or ARB will be switched to sacubitril\u002Fvalsartan 50mg twice daily (24.3 mg sacubitril, 25.7mg valsartan) for two weeks, increased to 100mg twice daily for three weeks, followed by 200mg twice daily",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Samuel S Mutasingwa, MD","Ifakara Health Iistitute","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Martin Rohacek, PD Dr med","CONTACT","+255625064252","+41774431815","mrohacek@ihi.or.tz",{"name":22,"role":28,"phone":33,"phoneExt":19,"email":34},"+255757383124","ssalvatory@ihi.or.tz",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":19,"country":41,"countryCode":19,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Heart and Lung Clinic, St Francis Regional Referral Hospital, Ifakara, Tanzania","RECRUITING","Ifakara","Morogoro","Tanzania",{"type":43,"coordinates":44},"Point",[45,46],36.68333,-8.13333,{"lat":46,"lon":45},[49,50],{"name":22,"role":28,"phone":33,"phoneExt":19,"email":34},{"name":51,"role":28,"phone":52,"phoneExt":19,"email":53},"Andrew Katende, MD","+255743191255","akatende@ihi.or.tz",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Martin Rohacek","Project Leader",[59],{"name":60,"class":61},"Ifakara Health Institute (IHI)","UNKNOWN","100570237","phase-4-sacubitril-valsartan-in-patients-with-heart-failure-with-reduced-ejection-fraction-from-rural-tanzania-100570237",false,"NCT06704633","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","Inclusion criteria\n\n* Symptomatic heart failure NYHA class II-IV and\n* Left ventricular ejection fraction (LVEF) ≤40% and\n* Treatment with an ACE Inhibitor or an ARB, beta-blocker, and spironolactone in recommended dosages for at least 3 months, and\n* Adherence to this therapy of at least 80%.\n\nExclusion criteria\n\n* Pregnancy\n* Systolic blood pressure of less than 95 mmHg,\n* eGFR below 30 ml per minute per 1.73 m2 of body-surface area\n* Serum potassium level of more than 5.4 mmol per liter\n* History of angioedema\n* Unacceptable side effects prior during receipt of ACE inhibitors or ARBs\n* Inability to sign an informed consent form.","ALL","18 Years",{"count":72,"type":73},298,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","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\u002Fvalsartan is registered under the name Uperio®.",[79],"Heart Failure",[81,82,83,84],"Sacubitril-valsartan","Heart failure with reduced ejection fraction,","HFrEF","KCCQ","2026-06-30",{"date":87,"type":88},"2026-07-02","ACTUAL",{"date":85,"type":88},{"date":91,"type":73},"2028-11-30",{"name":56,"class":6},1]