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NCT Number: NCT05858944

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.

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community hospitals

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Yan Li, Professor

CONTACT

[email protected]

+8613482234463

Yan Li, Professor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Home BP<125/75 mmHg

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.

Other names: Home BP<135/85 mmHg

Primary outcomes

  1. Composite of adverse cardiovascular events

    Time frame: 48 months

    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.

Secondary outcomes

  1. Components of the primary outcome

    Time frame: 48 months

    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).

  2. Renal outcome

    Time frame: 48 months

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

  3. Adverse or severe adverse events

    Time frame: 48 months

    Especially dizziness and falls caused by hypotension, and orthostatic hypotension

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Li, Professor

CONTACT

[email protected]

+8613482234463

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Hypertension

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
May 15, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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