Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes-----renal Substudy
Status:
Not yet recruiting
Trial end date:
2028-07-31
Target enrollment:
Participant gender:
Summary
Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse
cardiovascular (CV) and renal events. Diabetic patients with hypertension benefit from BP
lowering treatment. The present trial, IPAD-CKD in brief, is a randomized, open-label,
parallel-designed, multicenter study involving nearly 5322 patients to be recruited over
three years and to be followed up for a median of four years and a half. IPAD-CKD 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 renal 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 double-blind 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.