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HFrEF Polypill in Sri Lanka RCT

RecruitingPhase 3Ages 18 Years - anyAllWashington University School of Medicine
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up. Primary outcome of the study: 1\) Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration Secondary outcomes of the study: 1. Rate of cardiovascular disease mortality over study duration 2. Rate of recurrent heart failure hospitalizations over the study duration 3. Rate of all-cause mortality over the study duration 4. Change in left ventricular ejection fraction at 12-months and end of study assessed by transthoracic echocardiogram 5. Change in BNP levels at 12 months and end of study 6. Change in overall and domain specific hea

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Adults (โ‰ฅ18 years old) 2. 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 left ventricular ejection fraction (EF โ‰ค40%) 3. New York Heart Association Class II, III, or IV symptoms Exclusion Criteria: 1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others). 2. Significant renal impairment (estimated glomerular filtration rate \<30 mL/min/1.73 m2). 3. Raised serum potassium \>5 mEq/L. 4. Symptomatic hypotension or systolic BP \<100 mmHg as per the average of last 2 of the 3 measurements at visit 1. 5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1. 6. History of type 1 diabetes mellitus. 7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using a highly acceptable form of contraception throughout the study (pharmacological or barrier methods). 8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary physician could interfere with the conduct of the study including outcome assessment. 9. 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. 10. Participant's responsible physician believes it is not appropriate for participant to participate in the study. 11. Inability or unwillingness to provide written informed consent. 12. Involvement in the planning and/or conduct of the study. 13. Unable to complete study procedures and/or plan to move out of the study site area in the next 12 months.
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What it tests

  • Usual Care
  • HFrEF Polypill
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Where

12 sites
National Hospital Kandy
Kandy, Sri Lanka
Teaching Hospital Anuradhapura
Anuradhapura, Sri Lanka
Teaching Hospital Kurunegala
Kurunegala, Sri Lanka
Teaching Hospital Jaffna
Jaffna, Sri Lanka
Rathnapura Teaching Hospital
Colombo, Sri Lanka
National Hospital Galle
Galle, Sri Lanka
National Hospital of Sri Lanka
Colombo, Sri Lanka
University Hospital - General Sir John Kotelawala Defence University
Colombo, Sri Lanka

โ€ฆand 4 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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