HFrEF polypill strategy in Sri Lanka

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 randomized trial evaluates the effect of an HFrEF polypill implementation strategy on the combined outcome of cardiovascular death and recurrent heart failure hospitalizations over at least 12 months. Secondary measures include changes in ejection fraction, BNP, all-cause mortality, and quality of life using a translated instrument. Participants are adults with HFrEF (EF ≤40%) and NYHA class II–IV, enrolled at sites in Sri Lanka and followed for up to 12 months or more. The intervention arm receives the HFrEF polypill in addition to usual care, while the control arm receives usual care alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (≥18 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 ≤40%)
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.

Where it's running

• National Hospital Kandy
  Kandy, Central Province, Sri Lanka Recruiting
• Teaching Hospital Kurunegala
  Kurunegala, North Western Province, Sri Lanka Recruiting
• Teaching Hospital Jaffna
  Jaffna, Northern Province, Sri Lanka Recruiting
• Rathnapura Teaching Hospital
  Colombo, Ratnapura, Sri Lanka Recruiting
• National Hospital Galle
  Galle, Southern Province, Sri Lanka Recruiting
• National Hospital of Sri Lanka
  Colombo, Western Province, Sri Lanka Recruiting

Study contacts

• Study coordinator: Anubha Agarwal, MD MSc
• Email: anubha@wustl.edu
• Phone: +1 314-362-1291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.