A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress.

Abstract

Objective. The optimal level of home blood pressure (HBP) for the prevention of cardiovascular complications is unknown. The Home Blood Pressure Intervention in the Community Trial (HomeBP, [NCT05858944]) is addressing this issue by randomising elderly hypertensive patients to standard or tight HBP control.Methods and analysis. HomeBP is an investigator-initiated randomised clinical trial with open design and blinded endpoint evaluation. Eligible patients of either sex, aged 60-80 years, having uncontrolled home hypertension (≥135/85 mm Hg) after medication for at least 2 weeks will be recruited nationwide in China at up to 200 community healthcare centres. After stratification for centre and the presence of office hypertension (≥140/90 mm Hg), 10,000 patients will be randomised in a 1:1 proportion to a target HBP of 125-134/75-84 mm Hg or <125/75 mm Hg and followed up for 4 years. The primary outcome is a composite of cardiovascular death, non-fatal myocardial infarction, coronary revascularisation, unstable angina pectoris or heart failure requiring hospitalisation, and non-fatal stroke. Follow-up visits are scheduled monthly for 3 months after randomisation and 3-monthly thereafter. Patients record HBP for 7 consecutive days before every visit. A unique feature of the trial is the information technology setup, allowing the secure and instantaneous flow of HBP and other data to the study coordinating centre, where a standardised HBP report is generated. Hypertension specialists at Ruijin Hospital, Shanghai and at local tertiary hospitals provide treatment recommendations, which are transmitted to the caregivers at the community centres, who then fine-tune the treatment recommendations in a shared decision process with the patients to meet the values and clinical needs of the patients. Currently, 2281 patients have been randomised with no between-group differences in the baseline characteristics.Trial registration number. URL: https://www.clinicaltrials.gov; Unique identifier: NCT05858944.