Study of Blood Pressure Treatment in Adults 45-79 With Type 2 Diabetes and High-Normal Blood Pressure

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 14090 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.

Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes