Home Blood Pressure
Conditions
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.
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.
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.
Sponsors
Shanghai Institute of Hypertension
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of adverse cardiovascular events | 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
| Measure | Time frame | Description |
|---|---|---|
| Components of the primary outcome | 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). |
| Renal outcome | 48 months | Including end stage renal disease (ESRD) and a decrease in the eGFR of 30% or more |
| Adverse or severe adverse events | 48 months | Especially dizziness and falls caused by hypotension, and orthostatic hypotension |
Countries
China
Contacts
Primary ContactYan Li, Professor
Outcome results
None listed