A randomised trial comparing usual versus strict home blood pressure control in elderly patients with hypertension: protocol and initial progress.
Dong-Yan Zhang, Yi-Qing Zhang, De-Wei An...
https://pubmed.ncbi.nlm.nih.gov/39993302Actively Recruiting
Phase Not Applicable
Age: 60Years - 80Years
All Genders
ID05858944
Home Blood Pressure Intervention in the Community Trial Comparing Lower vs. Standard Home Blood Pressure Targets in Older Adults with Hypertension
Led by Shanghai Institute of Hypertension · Updated on 2025-01-06
10000
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether setting a lower home blood pressure target (125/75 mmHg) compared to a standard target (135/85 mmHg) can reduce the risk of cardiovascular events in elderly patients with high blood pressure who are already receiving treatment. The study also seeks to encourage the use of standardized and technology-based home blood pressure monitoring to improve management of hypertension in the community. This trial involves participants aged 60 to 80 years who have been on antihypertensive medication for more than two weeks and have elevated home blood pressure readings. Participants are assigned to one of two groups: an intensive home blood pressure control group targeting the lower blood pressure goal, and a standard home blood pressure control group aiming for the higher target. If the blood pressure goals are not met during follow-up, the types and doses of antihypertensive medications will be adjusted based on current guidelines and the treating physician's judgment. Home blood pressure monitoring is conducted over several days to ensure accurate readings and guide treatment adjustments. During the study, participants will regularly measure their blood pressure at home, and researchers will collect data on cardiovascular events over a 48-month period to assess the impact of the different blood pressure targets. The study includes close monitoring for safety and compliance, with follow-up visits to adjust treatment as needed. The total duration of participation spans four years, allowing thorough observation of treatment effects and cardiovascular outcomes in the elderly population.
CONDITIONS
Official Title
Home Blood Pressure Intervention in the Community Trial
Who Can Participate
Age: 60Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 60-80 years old
- Have been taking antihypertensive drugs for more than 2 weeks
- Average systolic and/or diastolic blood pressure of 135/85 mmHg or higher based on 7-day home blood pressure monitoring
- Willing to participate, follow up regularly, and sign the informed consent form
You will not qualify if you...
- Arm circumference too small (less than 18 cm) or too large (greater than 42 cm) to fit the blood pressure cuff
- Invalid home blood pressure monitoring (less than 3 consecutive days with at least 1 morning and 1 evening measurement per day)
- Office blood pressure at stage 3 hypertension level (180/110 mmHg or higher) during screening
- Suspected or confirmed secondary hypertension
- Orthostatic hypotension defined as a drop in systolic blood pressure over 20 mmHg or diastolic over 10 mmHg within 3 minutes of standing
- Severe kidney disease with eGFR less than 30 ml/min/1.73m2 or end-stage renal disease
- Cardiovascular events such as heart attack, stroke, acute heart failure, unstable angina hospitalization, or coronary artery procedures within the past 3 months
- Abnormal liver function tests more than twice the normal limit
- Severe serious illness with less than 3 years life expectancy or cancer diagnosis within the past 2 years requiring treatment
- Participation deemed harmful or poor compliance expected by doctors
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
Community hospitals
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
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Research Team
Y
Yan Li, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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