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Home Blood Pressure Intervention in the Community Trial

ConditionHome Blood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorShanghai Institute of Hypertension

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

10,000 Participants
are divided into 2 treatment groups
Group A: Intensive Home BP ControlExperimental treatment 1 intervention
Group B: Standard Home BP ControlActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Institute of Hypertension

Lead sponsor

Source ClinicalTrials.gov
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