Home Blood Pressure Intervention in the Community Trial

Overview

The primary purpose of the study is to explore whether a lower home blood pressure target (125/75 v.s. 135/85 mmHg) would be beneficial to elderly treated hypertensive patients in terms of reduced incidence of cardiovascular events. The study also aims to promote the application of standardised and information-based home blood pressure monitoring in community hypertension management.

Interventions

• Drug Intensive Home BP control
  If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.
• Drug Standard Home BP control
  If the target home BP level is not achieved during the follow-up periods, type and dosage of antihypertensive drugs will be adjusted according to current guidelines and physician's clinical experience.

Primary outcome measures

• Composite of adverse cardiovascular events [Time frame: 48 months]

Secondary outcome measures (3)

• Components of the primary outcome [Time frame: 48 months]
• Renal outcome [Time frame: 48 months]
• Adverse or severe adverse events [Time frame: 48 months]

Eligibility criteria

Inclusion criteria

• Aged 60-80 years old
• Have been taking antihypertensive drugs for more than 2 weeks
• The average SBP and/or DBP of 7-day home blood pressure monitoring ≥135/85 mmHg
• Willing to participate, adhere to follow-up, and sign the written informed consent form

Exclusion criteria

• Arm circumference too large or too small (less than 18 cm or greater than 42 cm) to fit the cuff in case of inaccurate measurement
• Invalid home blood pressure monitoring. The valid home blood pressure monitoring requires consecutive measurements for at least 3 days, with not less than 1 measurement in the morning and evening, respectively.
• Office blood pressure indicates stage 3 clinic hypertension (≥180/110 mmHg) during the screening period
• Suspected or known secondary hypertension
• Orthostatic hypotension, defined as a decrease in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg within 3 minutes when position is changed from sitting to standing
• eGFR<30 ml/min/1.73m2 or end-stage renal disease
• Cardiovascular events occured within the past 3 months, such as myocardial infarction, stroke, acute heart failure, hospitalization for unstable angina, undergoing coronary artery revascularization or bypass grafting
• Abnormal liver function (ALT/AST/total bilirubin more than 2 times the upper limit of normal value)
• Severe somatic disease with a life expectancy of less than 3 years, or diagnosed with cancer within the past 2 years requiring treatment
• Doctors deem that the participation would do harm to the patients or the patients would have poor compliance.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Community hospitals — Shanghai

Publications

• Zhang DY, Zhang YQ, An DW, Cheng YB, Tang ST, Liu M, Li J, Staessen JA, Wang JG, Li Y; HomeBP Trial Investigators. A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress. Blood Press. 2025 Dec;34(1):2472192. doi: 10.1080/08037051.2025.2472192. Epub 2025 Mar 2. PMID 39993302

Identifiers

NCT: NCT05858944 · 1.1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗