Home Blood Pressure Intervention in the Community Trial

Shanghai Institute of Hypertension

Status: Enrolling

Conditions: Home Blood Pressure

Treatments: Drug: Standard Home BP control; Drug: Intensive Home BP control

Study type: Interventional

Funder types: Other

Identifiers

NCT05858944

1.1

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 2 patient groups

Intensive Home BP Control

Experimental group

Description:

Participants randomized into the intensive treatment arm will have a goal of home BP\<125/75 mmHg.

Treatment:

Drug: Intensive Home BP control

Standard Home BP Control

Active Comparator group

Description:

Participants randomized into the standard treatment arm will have a goal of home BP within 125-134/75-84 mmHg.

Treatment:

Drug: Standard Home BP control