Rationale and design for the Blood Pressure Control Target in Diabetes (BPROAD) study.

Background: Diabetes and hypertension are major modifiable risk factors for cardiovascular disease. Previous clinical trials have demonstrated that intensive blood pressure reduction lowers the risk of cardiovascular disease and all-cause mortality compared to standard blood pressure reduction among patients without diabetes. However, optimal levels of blood pressure control in patients with diabetes remain uncertain.

Methods: The Blood Pressure Control Target in Diabetes (BPROAD) study is a multicenter, randomized controlled trial conducted in mainland China. We plan to enroll 12 702 participants aged ≥50 years with type 2 diabetes, an increased cardiovascular risk, and systolic blood pressure ≥130 mm Hg from 150 study centers. Participants are randomly assigned to intensive (a systolic target of <120 mm Hg) or standard (a systolic target of <140 mm Hg) blood pressure treatment group. Participants will be followed monthly for blood pressure management in the first 3 months and then every 3 months afterward. The primary study outcome is a composite of major cardiovascular events including nonfatal myocardial infarction, nonfatal stroke, treated or hospitalized heart failure, and cardiovascular death. Data will be collected every 3 months for up to 5 years and a blinded outcome committee will adjudicate all clinical outcomes. The BPROAD study is designed to have 90% statistical power to detect a 20% reduction in the primary study outcome at a two-sided significance level of 0.05.

Conclusions: The BPROAD study will provide important evidence as to whether intensive blood pressure management has additional benefits on cardiovascular disease and all-cause mortality among patients with type 2 diabetes.