[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636742":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":25,"responsibleParty":40,"collaborators":42,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":25,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":78,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":25},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm","ACTIVE_COMPARATOR","Participants in the comparator control arm will receive usual care, as per their physician's discretion.",[13],"Other: Comparator Arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Study Intervention arm","EXPERIMENTAL","Participants in the intervention group will be provided the HFrEF polypill by the study.",[19],"Drug: HFrEF Polypill",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Comparator Arm","Participants in the comparator control group will receive usual care by their healthcare providers. Providers will be encouraged to treat all participants according to international and local clinical practice guidelines.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","HFrEF Polypill","The heart failure with reduced ejection fraction (HFrEF) polypill will include 4 guideline recommended medications used to treat HFrEF patients. The dose of initiation and titration will be at the investigator's discretion.\n\nHFrEF polypill strength 1: bisoprolol 2.5 mg + losartan 25 mg + eplerenone 25 mg + dapagliflozin 10 mg; HFrEF polypill strength 2: bisoprolol 5 mg + losartan 50 mg + eplerenone 25 mg + dapagliflozin 10 mg; HFrEF polypill strength 3: bisoprolol 10 mg + losartan 100 + eplerenone 50 mg + dapagliflozin 10 mg",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Anubha Agarwal, MD MSc","CONTACT","314-362-1291","anubha@wustl.edu",{"name":38,"role":34,"phone":25,"phoneExt":25,"email":39},"Adam Hively, MPH","adamh@wustl.edu",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[43,45,47,50],{"name":44,"class":6},"The George Institute",{"name":46,"class":6},"Centre for Chronic Disease Control, India",{"name":48,"class":49},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":51,"class":52},"RemediumOne","UNKNOWN","100636742","phase-3-hfref-polypill-in-sri-lanka-rct-100636742",false,"NCT07569640","HFrEF Polypill in Sri Lanka RCT","Heart Failure With Reduced Ejection Fraction Polypill in Sri Lanka: A Multi-Center Type I Hybrid Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥18 years old)\n2. Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced ejection fraction (EF≤40%)\n3. New York Heart Association Class II, III, or IV symptoms\n\nExclusion Criteria:\n\n1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).\n2. Significant renal impairment (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n3. Raised serum potassium \\>5 mEq\u002FL.\n4. Symptomatic hypotension or systolic BP \\\u003C100 mmHg as per the average of last 2 of the 3 measurements at visit 1.\n5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.\n6. History of type 1 diabetes mellitus.\n7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using medically acceptable form of contraception throughout the study (pharmacological or barrier methods).\n8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team\u002F primary physician could interfere with the conduct of the study including outcome assessment.\n9. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n10. Participant's responsible physician believes it is not appropriate for participant to participate in the study.\n11. Inability or unwillingness to provide written informed consent.\n12. Involvement in the planning and\u002For conduct of the study.\n13. Unable to complete study procedures and\u002For plan to move out of the study site area in the next 2 months.","ALL","18 Years",{"count":63,"type":64},1656,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","Primary Outcome:\n\nComposite of cardiovascular death or recurrent heart failure hospitalization over study duration\n\nSecondary Outcomes:\n\nCardiovascular death over study duration Recurrent heart failure hospitalizations over study duration All-cause mortality over study duration Change in left ventricular ejection fraction from baseline to 12 months by echocardiogram.\n\nChange in natriuretic peptide levels from baseline to 12 months. Change in health-related quality of life from baseline to 12 months using the Kansas City Cardiomyopathy Questionnaire.\n\nChange in New York Heart Association functional class from baseline to 12 months.\n\nAdherence to heart failure medications assessed by pill count and questionnaire, medication persistence assessed as continuation of assigned therapy after initiation, and dose optimization assessed as proportion achieving final\u002Ftarget doses over study duration\n\nSafety Outcomes:\n\nProportion of participants with serious adverse events or sudden unexpected serious adverse reaction over study duration Proportion with adverse events of special interest (symptomatic hypotension, diabetic ketoacidosis, severe hypoglycemia, lower limb amputation, hyperkalemia, or worsening kidney function) over study duration Proportion of participants who stop study drug because of adverse events over study duration Change in serum potassium over study duration Change in serum creatinine over study duration\n\nParticipants will be randomly assigned to one of two groups, intervention or usual care. The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options (at the discretion of their treating physician). Both groups will be observed over a minimum of 12-months of follow-up to assess their medication adherence, clinical symptoms, laboratory measures, health related quality of life, and need for medication adjustment amongst other measures.",[70],"Heart Failure With Reduced Ejection Fraction",[72,73,74,75,76,77],"HFrEF","Heart Failure","Heart Failure with Reduced Ejection Fraction","South Asia","Sri Lanka","Polypill","NOT_YET_RECRUITING","2026-05-14",{"date":81,"type":82},"2026-05-18","ACTUAL",{"date":84,"type":64},"2026-06-01",{"date":86,"type":64},"2029-03-01",{"name":5,"class":6}]