Home Blood Pressure Intervention in the Community Trial

NCT05858944 | Recruiting

• 1 other identifier: 1.1
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Home Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Components of the primary outcome

  48 months

• Renal outcome

  48 months

• Adverse or severe adverse events

  48 months

Study Arms (2)

Intensive Home BP Control

EXPERIMENTAL

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

Drug: Intensive Home BP control

Standard Home BP Control

ACTIVE COMPARATOR

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

Interventions

Intensive Home BP control DRUG

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.

Also known as: Home BP<125/75 mmHg

Intensive Home BP Control

Standard Home BP control DRUG

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.

Also known as: Home BP<135/85 mmHg

Standard Home BP Control

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Hypertension: lead

Study Sites (1)

Community hospitals

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Yan Li, Professor

  Shanghai Institute of Hypertension

  PRINCIPAL INVESTIGATOR

• Jiguang Wang, Professor

  Shanghai Institute of Hypertension

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Li, Professor

CONTACT

+8613482234463; liyanshcn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctor of Medicine, Doctor of Philosophy

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: May 6, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

CN (1)