Clinical trial NCT05858944: Home Blood Pressure Intervention in the Community Trial
Official title: Home Blood Pressure Intervention in the Community Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Home Blood Pressure
Lead sponsor: Shanghai Institute of Hypertension
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 10000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Composite of adverse cardiovascular events
timeFrame: 48 months
Secondary outcomes:
measure: Components of the primary outcome
timeFrame: 48 months
measure: Renal outcome
timeFrame: 48 months
measure: Adverse or severe adverse events
timeFrame: 48 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Community hospitals
state: Shanghai
Study officials:
affiliation: Shanghai Institute of Hypertension
name: Yan Li, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Institute of Hypertension
name: Jiguang Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: