Home Blood Pressure Intervention in the Community Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Home Blood Pressure
• Intervention / Treatment: Drug: Intensive Home BP control; Drug: Standard Home BP control

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Li, Professor; Phone Number: +8613482234463; Email: liyanshcn@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Community hospitals
      • Contact: Yan Li, Professor; Phone Number: +8613482234463; Email: liyanshcn@163.com
      • Contact: Yan Li, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Home BP Control; Participants randomized into the intensive treatment arm will have a goal of home BP<125/75 mmHg.	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.; Other Names: Home BP<125/75 mmHg
Active Comparator: Standard Home BP Control; 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; 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.; Other Names: Home BP<135/85 mmHg

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Institute of Hypertension
• Investigators: Principal Investigator: Yan Li, Professor, Shanghai Institute of Hypertension; Principal Investigator: Jiguang Wang, Professor, Shanghai Institute of Hypertension

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No