BPROAD 2019.

Study name	BPROAD study
Methods	Multicentre, open‐label, parallel‐group, randomized controlled trial that will be conducted across mainland China. Expected follow‐up: 5 years
Participants	Inclusion criteria: men and women aged ≥ 50 years; diabetes defined as: a self‐reported previous diagnosis by healthcare professionals and taking antidiabetic medications; fasting plasma glucose level ≥ 126 mg/dL (7.0 mmol/L); SBP ≥ 140 mmHg on 0 medication; 130–180 mmHg on 1 medication; 130–170 mmHg on up to 2 medications; 130–160 mmHg on up to 3 medications; or 130–150 mmHg on up to 4 medications; increased risk of CVD. Exclusion criteria: history consistent with type 1 diabetes; known secondary cause of hypertension; 1‐minute standing SBP < 110 mmHg; arm circumference too large to allow accurate blood pressure measurement with available devices; cardiovascular event or procedure or hospitalization for unstable angina within past 3 months; symptomatic heart failure within past 6 months or left ventricular ejection fraction (by any method) < 35% within the past 6 months; ALT or AST levels more than twice the upper limit of the normal range or active liver diseases; dialysis, kidney transplantation, eGFR < 30 mL/minute/1.73 m², or sCR > 2.0 mg/dL; proteinuria; previous diagnosis of polycystic kidney disease or glomerulonephritis; a medical condition likely to limit survival to < 5 years; any factors judged by the clinic team to be likely to limit adherence to interventions; failure to obtain informed consent from participant; currently participating in another intervention study; currently living with another BPROAD participant; pregnancy, currently trying to become pregnant, or of child‐bearing potential and not using contraception.
Interventions	Standard target: SBP < 140 mmHg Lower target: SBP < 120 mmHg
Outcomes	Primary outcome: major cardiovascular events. Secondary outcomes: composite of the primary outcome and all‐cause mortality; macrovascular outcomes; major coronary artery diseases; total stroke; heart failure; cardiovascular death; total mortality; cognitive function; health‐related quality of life; kidney outcomes.
Starting date	February 2019
Contact information	Guang Ning, MD, PhD; XUYANRR@yahoo.com.cn
Notes	Sponsor: Shanghai Jiao Tong University School of Medicine