Study setting and participants
hypertension, cardiometabolic diseases, lower extremity arteryCoronary artery calcium, unstable angina, microalbuminuria, polycystic kidney disease, stentingPeripheral artery disease, revascularizationAcute coronary syndrome, Diabetes, heart failure, type 2 diabetes, stenosis
CARDIOVASCULAR DISEASE, HYPERTENSION, CVD, EVENT, UNSTABLE ANGINA, GLOMERULONEPHRITIS, POLYCYSTIC KIDNEY DISEASE, SECONDARY, DIABETES, BLOOD, HEART FAILURE, TYPE 2 DIABETES, STENOSIS, VENTRICULAR HYPERTROPHY
Participating centers are recruited from all over mainland China. To be eligible, a BPROAD participating center should (a) be a government‐approved secondary or tertiary hospital, (b) have ≥500 type 2 diabetes patients per year, (c) have a well‐accredited medical laboratory for clinical measurements, (d) have at least two study physicians with expertise in cardiometabolic diseases and one study assistant, and (e) be willing to participate in the trial and comply with trial protocol.Participants are recruited at each participating center. The inclusion and exclusion criteria of BPROAD participants are presented in Table Inclusion and exclusion criteria of study participants.Inclusion criteriaAge ≥50 yearsType 2 diabetesSystolic blood pressure≥140 mm Hg without taking any antihypertensive drug; or130–180 mm Hg on 1 antihypertensive drug; or130–170 mm Hg on up to 2 antihypertensive drugs; or130–160 mm Hg on up to 3 antihypertensive drugs; or130–150 mm Hg on up to 4 antihypertensive drugsIncreased risk of CVD (one or more of the following):Previous history of clinical CVD (≥3 months)StrokeMyocardial infarctionPCI or CABGCarotid endarterectomy or carotid stentingPeripheral artery disease with revascularizationAcute coronary syndrome
Subclinical CVD within 3 yearsMicroalbuminuria≥50% stenosis of a coronary, carotid, or lower extremity arteryCoronary artery calcium score ≥ 400 Agatston unitsAnkle brachial index ≤0.90Left ventricular hypertrophyIf microalbuminuria is the only criterion satisfied for increased risk of cardiovascular disease, replication to confirm is required.Two or more CVD risk factorsCurrent cigarette smokingBMI ≥28 kg/mCurrent lipid‐lowering medications or LDL‐C ≥130 mg/dL (3.38 mmoL/L)Current lipid‐lowering medications or HDL‐C <40 mg/dL (1.04 mmoL/L)Current lipid‐lowering medications or triglycerides ≥150 mg/dL (1.69 mmoL/L)eGFR: 30–59 mL/min/1.73 m
Exclusion criteriaHistory consistent with type 1 diabetesKnown secondary cause of hypertension (including procedures for renal artery disease)One‐minute standing systolic BP <110 mm HgArm circumference too large to allow accurate BP measurement with available devicesCardiovascular event or procedure (as defined above as clinical CVD for study entry) or hospitalization for unstable angina within the past 3 monthsSymptomatic heart failure or left ventricular ejection fraction (by any method) <35% within the past 6 monthsALT or AST levels more than twice the upper limit of the normal range or active liver diseasesDialysis or renal transplantation, or eGFR <30 mL/min/1.73 mProteinuria24‐h urinary protein excretion ≥1 g/day, or24‐h urinary albumin excretion ≥600 mg/day, orSpot urine protein/creatinine ratio ≥1 g/g, orAlbumin/creatinine ratio ≥600 mg/gPrevious diagnosis of polycystic kidney disease or glomerulonephritisA medical condition likely to limit survival to less than 5 yearsAny factors judged by the clinical team to be likely to limit adherence to interventionsFailure to obtain informed consent from participantCurrently participating in another intervention studyCurrently living with another BPROAD participantPregnancy, currently trying to become pregnant, or of child‐bearing potential and not using birth controlAbbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; BPROAD, Blood Pressure Control Target in Diabetes; CABG, coronary artery bypass graft; CVD, cardiovascular disease; ECG, electrocardiogram; eGFR, estimated glomerular filtration rate; HDL‐C, high‐density lipoprotein cholesterol; LDL‐C, low‐density lipoprotein cholesterol; PCI, percutaneous coronary intervention.All study documents such as the study protocol, manual of procedures, and informed consent were approved in advance by the Institutional Review Board (IRB) of Ruijin Hospital, as well as by the IRBs of participating study centers. Written informed consent is obtained from all study participants.