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

Summary

Participation Requirements

Description

The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited over three years with a median follow up of 4.5 years. IPAD tests the hypothesis that intensive antihypertensive medical therapy in adult patients with type 2 diabetes, whose seated BP...

The IPAD trial is a randomized, open-label, parallel-designed, multicenter study. 11,414 patients will be recruited over three years with a median follow up of 4.5 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; end-stage renal disease; development of diabetic retinopathy that needs interventional operation; peripheral arterial diseases; new on-set atrial fibrillation or flutter; cancer; change 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, 844 primary endpoints are expected to occur. Interim analyses will be carried out on an intention-to-treat basis at the accumulation of 281 and 563 primary endpoints respectively. At the completion of the trial, both an intention-to-treat and a per-protocol analysis will be performed.

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