A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress
Creators: name: Zhang, Dong-Yan
name: Zhang, Yi-Qing
name: An, De-Wei
name: Cheng, Yi-Bang
name: Tang, Song-Tao
name: Liu, Min
name: Li, Jue
name: Staessen, Jan A.
name: Wang, Ji-Guang
name: Li, Yan
Publisher: name: Taylor & Francis
Year: 2025
Subjects: subject: Medicine
subject: Cell Biology
subject: Physiology
subject: FOS: Biological sciences
subject: Biotechnology
subject: Marine Biology
subject: Science Policy
subject: Computational Biology

description: 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. 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 &lt;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. What is the context?A lower blood pressure target was associated with lower incidence of cardiovascular complications. However, in all previous trials comparing standard to tight blood pressure control was guided by office blood pressure.The optimal level of home blood pressure (HBP) for the prevention of cardiovascular complications is unknown. A lower blood pressure target was associated with lower incidence of cardiovascular complications. However, in all previous trials comparing standard to tight blood pressure control was guided by office blood pressure. The optimal level of home blood pressure (HBP) for the prevention of cardiovascular complications is unknown. What is new?The Home Blood Pressure Intervention in the Community Trial (HomeBP, [NCT05858944]) compares usual versus strict home blood pressure control in elderly patients with hypertension.Eligible patients of either sex, aged 60–80 years, having uncontrolled HBP (≥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 &lt;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.Currently, 2281 patients have been randomised with no between-group differences in the baseline characteristics. The Home Blood Pressure Intervention in the Community Trial (HomeBP, [NCT05858944]) compares usual versus strict home blood pressure control in elderly patients with hypertension. Eligible patients of either sex, aged 60–80 years, having uncontrolled HBP (≥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 &lt;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. Currently, 2281 patients have been randomised with no between-group differences in the baseline characteristics. What is the impact?The HomeBP trial will answer the highly relevant clinical question to which level the HBP should be reduced to provide maximal benefit in terms of the prevention of cardiovascular complications. The HomeBP trial will answer the highly relevant clinical question to which level the HBP should be reduced to provide maximal benefit in terms of the prevention of cardiovascular complications.