Heart Failure With Reduced Ejection Fraction Polypill Implementation Strategy in Sri Lanka

Summary

The primary objective of this trial is to see if the research team can successfully recruit participants and carry out study related procedures in Sri Lanka. This will help the research team plan and execute a future large-scale trial in Sri Lanka. The secondary objective is to assess whether a polypill for patients with heart failure with reduced ejection fraction (a type of heart condition) may help patients adhere to medications without an increase in serious adverse events. An exploratory objective is to understand the process of implementation. Participants 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 4-weeks 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.

Timeline

Start

2025-02-15

Primary completion

2025-05-05

Completion

2025-05-05

Publications

• Agarwal A, de Silva A, Agarwal M, Ajanthan S, Dahanayaka A, Dhurjati R, Fernando C, Galappatthy G, Goss CW, Hively A, Jayagopal PB, Mohanan PP, Patel A, Prabhakaran D, Rahuman M, Rodgers A, Roberts K, Salwa H, Huffman MD, Salam A. Heart failure with reduced ejection fraction polypill implementation strategy in Sri Lanka: design and protocol of a pilot type I hybrid randomised clinical trial. BMJ Open. 2025 Jul 15;15(7):e100952. doi: 10.1136/bmjopen-2025-100952.

Drugs

Indications