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RecruitingNCT05858944Updated Jan 6, 2025

Home Blood Pressure Intervention in the Community Trial

An interventional study of Intensive Home BP control and Standard Home BP control in Home Blood Pressure, sponsored by Shanghai Institute of Hypertension. Recruiting at 1 site in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Shanghai Institute of Hypertension · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10,000
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Home Blood Pressure
03

In context

Lead sponsor

Shanghai Institute of Hypertension is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10,000 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugIntensive 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.

    Also known as: Home BP<125/75 mmHg

  • DrugStandard 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.

    Also known as: Home BP<135/85 mmHg

06

What researchers measure

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.

    Time frame: 48 months

Secondary outcomes

  1. 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).

    Time frame: 48 months

  2. Renal outcome

    Including end stage renal disease (ESRD) and a decrease in the eGFR of 30% or more

    Time frame: 48 months

  3. Adverse or severe adverse events

    Especially dizziness and falls caused by hypotension, and orthostatic hypotension

    Time frame: 48 months

07

Study locations

1 of 1 sites recruiting
  • Community hospitals
    Shanghai, Shanghai 200025, China
    • Yan Li, Professor · Contact · liyanshcn@163.com · +8613482234463
    • Yan Li, Professor · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05858944
Lead sponsor
Shanghai Institute of Hypertension
Responsible party
Yan Li (Professor, Doctor of Medicine, Doctor of Philosophy, Shanghai Institute of Hypertension) — Principal investigator
First posted
May 15, 2023
Start date
May 6, 2023
Primary completion
Dec 31, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Jan 6, 2025

Study contacts

Yan Li, Professor
Contact
liyanshcn@163.com
+8613482234463
Yan Li, Professor
principal investigator · Shanghai Institute of Hypertension
Jiguang Wang, Professor
principal investigator · Shanghai Institute of Hypertension

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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