Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility.

This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes.

The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the National Medicines Regulatory Authority (Sri Lanka). The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.

Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).

High blood pressure (BP) is a significant global health issue, with many treated patients failing to achieve BP control. The Triple Pill vs Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial evaluated the effectiveness, cost-effectiveness and acceptability of early use of low-dose triple fixed-dose combination of BP-lowering drugs (‘triple pill’) compared with usual care in the management of hypertension. The TRIUMPH trial showed superior BP control with the triple pill strategy compared with usual care. This process evaluation of the TRIUMPH trial aimed to explore the contextual factors that influenced the trial outcomes, implementation of the triple pill strategy, mechanisms of its effects and potential barriers and facilitators for implementing the triple pill strategy in routine practice.

Guided by the UK Medical Research Council’s framework, semistructured interviews were conducted with 23 patients and 13 healthcare providers involved in the TRIUMPH trial. Data were analysed using the framework analysis method in NVivo.

Hypertension care in Sri Lanka was hindered by the absence of systematic screening and overcrowded public clinics. Despite free medication provision at public clinics, long waiting times and occasional stock-outs posed challenges. In the TRIUMPH trial, both intervention and usual care were delivered in the context of ‘better than usual’ care, including team-based management, reduced waiting times, monetary assistance for travel, routine adherence monitoring and intensive follow-up. The triple pill strategy provided a simplified regimen, better access to BP-lowering medications and better BP-lowering efficacy. Key barriers to implementation in routine practice included the triple pill’s large size, therapeutic inertia and restrictive regulatory policies regarding fixed-dose combinations.

Implementation of the triple pill strategy into routine practice requires health system strengthening, provider training and supportive policy measures to replicate its effectiveness seen in the trial.

ACTRN12612001120864, SLCTR/2015/020.

To compare cardiovascular mortality (ischaemic heart disease (IHD), hypertensive disease (HTN) and cerebrovascular disease (CeVD)) of 40–69-year-old Sri Lankans from 1980 to 2010 by age, birth cohort and sex.

A comparative retrospective study.

Sri Lanka.

40–69-year-old Sri Lankans from 1980 to 2010.

Cardiovascular deaths due to IHD, HTN and CeVD.

Mortality due to IHD increased with age but decreased with birth cohorts with time (range 3.7–390 per 100 000 population); there was a spike in the IHD mortality rates in both age groups and birth cohorts in 2000. Deaths due to HTN markedly increased after 55 years; however, mortality decreased in the younger cohorts (range 2.8–204.81 per 100 000 population). CeVD mortality linearly increased with age (range 3.3–153.3 per 100 000 population); birth cohorts of 1926–1930 and 1931–1935 had a spike in mortality among the 60–64 and 65–69 age groups, respectively. Changes were seen among both males and females; mortality rates were higher in males than in females.

All cardiovascular mortality rates increased with age and are higher in males than in females. Age-specific cardiovascular mortality rates were lower in the younger birth cohorts as compared with the older birth cohorts. The increase in cardiovascular deaths in Sri Lanka is due to the ageing population.