Lowering home blood pressure targets for elderly patients

Home Blood Pressure Intervention in the Community Trial

This study tests if lowering the home blood pressure target for older adults can help prevent heart problems and improve their health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10000 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Institute of Hypertension (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05858944 on ClinicalTrials.gov

What this trial studies

This study investigates whether setting a lower target for home blood pressure (125/75 mmHg) compared to a standard target (135/85 mmHg) can reduce cardiovascular events in elderly patients with hypertension. It involves intensive home blood pressure control and aims to standardize home monitoring practices in community settings. Participants will be elderly individuals aged 60-80 who have been on antihypertensive medication for at least two weeks and have elevated home blood pressure readings.

Who should consider this trial

Good fit: Ideal candidates are elderly individuals aged 60-80 who are currently taking antihypertensive medications and have elevated home blood pressure.

Not a fit: Patients with stage 3 hypertension or those with conditions that affect blood pressure measurement may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better cardiovascular health outcomes for elderly patients with hypertension.

How similar studies have performed: Other studies have shown promising results with similar approaches to blood pressure management, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Community hospitals — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yan Li, Professor — Shanghai Institute of Hypertension
• Study coordinator: Yan Li, Professor

Conditions Home Blood Pressure