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

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular (CV) 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 over three years and to be followed up for a median of four years and a half. 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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiyan Chen
• Treatments: Amlodipine; Hydrochlorothiazide

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;

• a glycosylated hemoglobin (HbA1c) ≤ 8.5%;

• informed consent provided and long-term follow-up possible

Exclusion Criteria:

• 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%, requiring treatment with renin-angiotensin system (RAS) blockers;

• 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/L) (ACR) ≥ 300 mg/g;

• known contraindications for the active study medications;

• a history of psychological or mental disorder;

• pregnancy or currently planning to have babies or lactation;

• severe diseases such as severe valvular heart diseases;

• an expected residual life span less than 3 years;

• a malignancy that clinical investigators consider as unsuitable to participate;

• currently participating in another clinical trial.