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HFrEF Polypill / Heart Failure With Reduced Ejection Fraction · Phase 3 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 3 randomized controlled trial of a polypill strategy versus usual care in adults with HFrEF in Sri Lanka, with a planned hard composite endpoint of cardiovascular mortality and recurrent hospitalization. The study is not yet recruiting and has no results posted; the registry entry describes only the planned design and endpoints.
Phase 3, Interventional, Randomized, Parallel, Single masking, Treatment purpose. Heart Failure With Reduced Ejection Fraction; age from 18 Years. Intervention: HFrEF Polypill. Compared with: Usual Care — Active Comparator. n = 1,672. 10 sites: Sri Lanka.
This is a registered Phase 3 randomized controlled trial of a polypill strategy versus usual care in adults with HFrEF in Sri Lanka, with a planned hard composite endpoint of cardiovascular mortality and recurrent hospitalization. The study is not yet recruiting and has no results posted; the registry entry describes only the planned design and endpoints.
Effect size, safety data, and efficacy outcomes are unknown and not available in this entry.
The source did not state who this applies to in practice.
This is a Phase 3 RCT registration with no results posted; the study is not yet recruiting, so no outcome data exist to evaluate.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07569640). This is a study registration, not published results. Lead sponsor: Washington University School of Medicine. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 1672 participants (ESTIMATED). Conditions: Heart Failure With Reduced Ejection Fraction. Interventions: OTHER: Usual Care; DRUG: HFrEF Polypill. Primary outcome measures: Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration , 1 month, 3 month, 6 month, 9 month, 12 month study visits, and every 3 months thereafter through study completion, an average of 18 months.. Brief summary: 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 health-related quality of life at 12-months and end of study assessed by a translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) 7. Change in physician-reported New York Heart Association class at 12-months and end of study 8. Adherence to guideline-directed medical therapy assessed by pill count and MARS-5 questionnaire at baseline, 1-, 6-, 12-months, and end of study. Persistence assessed as continuation of assigned therapy at each follow-up visit. Dose optimization assessed as proportion achieving target doses (Strength 3 of the polypill, or comparable individual GDMT doses in the comparator arm) at 6-, 12-months, and end of study. Safety outcomes: 1. Proportion of participants with serious adverse events according to Good Clinical Practice guidelines over study duration 2. Proportion of participants with adverse events of special interest over study duration 3. Proportion of participants with adverse events leading to HF drug discontinuation over study duration 4. Mean change from baseline to 12-months and end of study in serum potassium (mEq/L) 5. Mean change from baseline to 12-months and end of study in serum creatinine (mg/dL) Participants will be randomly assigned 1:1 stratified by sex and site to one of two groups, intervention (experimental arm) or usual care (control arm). 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. Both groups will be observed over a minimum of 12-months of follow-up to assess key outcomes.
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