Abstract
Abstract Background The World Health Organization (WHO) promotes the HEARTS technical package for improving hypertension control worldwide, but its effectiveness has not been rigorously evaluated. Methods A matched-pair cluster quasi-experimental trial in Upazila Health Complexes (UHCs; primary healthcare facilities) was conducted in rural Bangladesh. A total of 3,935 patients (mean age 52.3 years, 70.5% female) with uncontrolled hypertension (blood pressure [BP] ≥140/90 mm Hg regardless of treatment history) were enrolled: 1,950 patients from 7 UHCs implementing HEARTS and 1,985 patients from 7 matched usual care UHCs. WHO-HEARTS package intervention components were 1) simplified treatment protocol, 2) reliable medication supply, 3) team-based care, 4) standardized follow-up, and 5) a digital information system to track patients’ BP and monitor program performance. The primary outcome was systolic BP at six months measured at the patient’s home; secondary outcomes were diastolic BP, hypertension control rate (<140/90 mm Hg), and loss to follow-up. Multivariable mixed-effect linear and Poisson models were conducted as appropriate. Results Baseline mean systolic BP was 158.4 mm Hg in the intervention group and 158.8 mm Hg in the usual care group. At six months, the primary outcome was obtained in 95.5% of participants. Compared to usual care, the intervention significantly lowered systolic BP (-23.7 mm Hg vs. -20.0 mm Hg; net difference -3.7 mm Hg, p<0.001) and diastolic BP (-10.2 mm Hg vs. -8.3 mm Hg; net difference -1.9 mm Hg, p<0.001) and improved hypertension control (62.0% vs. 49.7%, net difference 12.3%, p<0.001). The occurrence of missed clinic visits was lower in the intervention group (8.8% vs. 39.3%, p<0.001). Conclusions In rural Bangladesh, WHO-HEARTS package implementation significantly lowered BP and improved hypertension control. These results support scale up of the WHO-HEARTS hypertension control package in Bangladesh and its implementation in other low- and middle-income countries. [ clinicaltrials.gov registration ID NCT04992039 ] Clinical Perspective: The Global Hearts Initiative is implementing a standard World Health Organization (WHO) HEARTS package for hypertension control in primary care clinics of 32 low- and middle-income settings. This quasi-experimental trial was completed alongside HEARTS program expansion in rural Bangladesh and is the first to rigorously assess the complete HEARTS package for hypertension. Compared with usual care, the WHO-HEARTS package significantly lowered blood pressure and improved hypertension control in hypertensive patients. WHO-HEARTS package implementation was feasible and effectively improved hypertension control in rural Bangladesh. The WHO-HEARTS is a standard and effective approach to improving hypertension control in low- and middle-income countries.