Home Blood Pressure Intervention in the Community Trial

Study Overview
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Brief Summary
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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.

Official Title
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Home Blood Pressure Intervention in the Community Trial

Conditions
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Home Blood Pressure

Intervention / Treatment
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* Drug: Intensive Home BP control
* Drug: Standard Home BP control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Home BP Control<br>Participants randomized into the intensive treatment arm will have a goal of home BP<125/75 mmHg. | Drug: Intensive Home BP control<br>* 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.<br>* Other names: Home BP<125/75 mmHg;|
| Active Comparator: Standard Home BP Control<br>Participants randomized into the standard treatment arm will have a goal of home BP within 125-134/75-84 mmHg. | Drug: Standard Home BP control<br>* 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.<br>* Other names: Home BP<135/85 mmHg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of adverse cardiovascular events | Composite of major adverse cardiovascular events consisting of death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina. | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Components of the primary outcome | Occurrence of any components of the primary outcome (death from cardiovascular diseases, non-fatal stroke, myocardial infarction, coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG]), hospitalization for heart failure or unstable agina). | 48 months | 
| Renal outcome | Including end stage renal disease (ESRD) and a decrease in the eGFR of 30% or more | 48 months | 
| Adverse or severe adverse events | Especially dizziness and falls caused by hypotension, and orthostatic hypotension | 48 months |