NCT03264352 Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes

Trial Parameters

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Brief Summary

Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg/day), 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.

Eligibility Criteria

Inclusion Criteria: * irrespective of sex; * aged between 45 and 79 years; * with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic; * diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy; * informed consent provided and long-term follow-up possible Exclusion Criteria: * poor control of blood glucose, HbA1c \> 10.0% * administration of any antihypertensive medications within 1 month; * a history of hypoglycemic coma / seizure; * confirmed diagnosis of type 1 diabetes mellitus; * alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal; * estimated glomerular filtration rate \< 45 ml/min/1.73m2; * a history of congestive heart failure with left ventricular ejection fraction \< 40%; * coronary artery disease requiring RAS blockers for secondary prevention; * acute on-set of stroke within 6 months prior to randomization; * a ratio of urinary albumin (in mg/L) to urinary creatinine (in g

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