Actively Recruiting
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes to Reduce Cardiovascular Events
Led by XueQing Yu · Updated on 2025-03-12
11414
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how lowering blood pressure affects adults with type 2 diabetes who have high-normal blood pressure. This large, randomized, open-label study involves over 11,000 participants aged 45 to 79 years with sitting systolic blood pressure between 120 and 139 mm Hg and diastolic below 90 mm Hg. The trial aims to see if intensive blood pressure control reduces major cardiovascular and cerebrovascular events by 20% compared to standard treatment. Participants are randomly assigned to one of two groups. The intensive group receives antihypertensive medications including Allisartan Isoproxil 240 mg daily and Amlodipine 5 to 10 mg daily to lower systolic pressure below 120 mm Hg. The standard group receives no medication until blood pressure reaches 140/90 mm Hg or higher, then treatment follows current guidelines to reduce it below those levels. The study will follow participants for a median of four years. Throughout the study, researchers will monitor cardiovascular events such as stroke, heart attack, hospitalizations for heart failure or unstable angina, and death. They will also assess kidney function, diabetic retinopathy, peripheral arterial disease, new atrial fibrillation, cancer, and quality of life. Blood pressure will be regularly measured to ensure targets are met. Safety and outcomes will be analyzed up to 60 months after randomization, with interim analyses planned during the study.
CONDITIONS
Brief Title
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any sex
- Age between 45 and 79 years
- Seated blood pressure 120-139 mm Hg systolic and below 90 mm Hg diastolic
- Diagnosed with type 2 diabetes mellitus and currently on diabetic therapy
- Provided informed consent and able to participate in long-term follow-up
You will not qualify if you...
- Poor blood glucose control with HbA1c above 10.0%
- Use of antihypertensive medications within the past month
- History of hypoglycemic coma or seizure
- Diagnosis of type 1 diabetes mellitus
- Liver enzymes (ALT or AST) more than three times the upper normal limit
- Estimated glomerular filtration rate below 45 ml/min/1.73m2
- History of congestive heart failure with ejection fraction below 40%
- Coronary artery disease needing RAS blockers for secondary prevention
- Stroke within 6 months before enrollment
- Urinary albumin to creatinine ratio 300 mg/g or higher
- Known contraindications to study medications
- History of psychological or mental disorder
- Pregnancy, planning pregnancy, or breastfeeding
- Severe diseases including severe heart diseases
- Expected life expectancy less than 3 years
- Malignancy deemed unsuitable by investigators
- Currently participating in another clinical trial
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants receive either intensive antihypertensive medication to reduce systolic blood pressure below 120 mm Hg or standard treatment to maintain systolic blood pressure below 140 mm Hg, with medications adjusted as needed.
Regular visits for medication management and monitoring during treatment
Duration - Up to 60 months
Participants are monitored for major cardiovascular events and other health outcomes after treatment initiation.
Periodic visits for health assessments and event monitoring
Trial Site Locations
Total: 1 location
1
Guangdong General Hospital
Guangzhou, Guangdong, China, 501080
Actively Recruiting
Research Team
J
Jiyan Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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