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

The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited in three years with a median follow up of four years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP ranges from 120 to 139 mm Hg systolic and \< 90 mm Hg diastolic, results in 20% reduction in the incidence of major adverse cardiovascular and cerebrovascular events (the primary endpoint), a composite of stroke, cardiovascular death, nonfatal myocardial infarction (MI), hospitalization for heart failure (HF) and hospitalization for unstable angina. Secondary endpoints of this study include: stroke; cardiovascular death; MI; hospitalization for HF; hospitalization for unstable angina; all-cause mortality; overt albuminuria; worsened renal function (the estimated glomerular filtration rate decreased by \> 30% from baseline); end-stage renal disease; development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer; decline of health-related quality of life. Inclusion criteria for the study include T2DM patients aged between 45 and 79 years within the aforementioned BP ranges. for participants in the intensive group, the sitting systolic BP should decrease to \< 120 mm Hg, using titration and combination of study medications consisting of an angiotensin type-1 receptor blocker Allisartan (240 mg/day) and a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg/day), and/or other medications if necessary.For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg. Across the whole study, 820 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.

• Stroke [Срок оценки: From date of randomization until the date of first documented incidence of stroke, assessed up to 60 months.]
• Cardiovascular Death [Срок оценки: From date of randomization until the date of cardiovascular death, assessed up to 60 months.]
• Acute Myocardial Infarction [Срок оценки: From date of randomization until the date of first documented incidence of acute MI, assessed up to 60 months.]
• Hospitalization of Unstable Angina [Срок оценки: From date of randomization until the date of first documented hospitalization of unstable angina, assessed up to 60 months.]
• Hospitalization of Congestive Heart Failure [Срок оценки: From date of randomization until the date of first documented hospitalization of HF, assessed up to 60 months.]
• All-cause Mortality [Срок оценки: From date of randomization until the date of death from any causes, assessed up to 60 months.]
• Overt Albuminuria [Срок оценки: From date of randomization until the date of confirmed development of overt albuminuria, assessed up to 60 months.]
• Worsened Renal Function [Срок оценки: From date of randomization until the date of first documented incidence of this event, assessed up to 60 months.]
• End-Stage Renal Disease [Срок оценки: From date of randomization until the date of documented diagnosis of end-stage renal disease, assessed up to 60 months.]
• Diabetic Retinopathy Requiring Interventional Operation or Surgery [Срок оценки: From date of randomization until the date of first documented interventional or surgical operation for diabetic retinopathy, assessed up to 60 months.]
• Peripheral Arterial Diseases Requiring Revascularization [Срок оценки: From date of randomization until the date of first documented revascularization for peripheral arterial diseases, assessed up to 60 months.]
• New Atrial Fibrillation or Flutter [Срок оценки: From date of randomization until the date of first documented incidence of atrial fibrillation or flutter, assessed up to 60 months.]