Hypertension, Type 2 Diabetes Mellitus
Conditions
Keywords
cardiovascular disease, rennin-angiotensin system, calcium channel blocker, impaired glucose tolerance
Brief summary
Various guidelines recommended angiotensin converting enzyme (ACE) inhibitors or angiotensin Ⅱ receptor-1 blockers (ARBs) for hypertensive patients with diabetes on the basis of the cardiac- and reno-protective effects of these drugs. However, these recommendations could not be extrapolated to Japanese patients, because Japan has been known as a country with a low incidence of coronary artery disease and a high incidence of cerebrovascular disease. Furthermore, calcium channel blockers (CCBs) also were protective against renal function as well as ACE inhibitors in Japanese diabetic hypertensive patients. This study will test whether ARBs or CCBs are superior in treating Japanese diabetic hypertensive patients.
Interventions
DRUGValsartan
valsartan 80 to 160 mg daily
DRUGAmlodipine
Amlodipine 5 to 10 mg daily.
Sponsors
Nagoya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of hypertension * Clinical diagnosis of type 2 diabetes or impaired glucose tolerance
Exclusion criteria
* History of congestive heart failure, myocardial infarction, or coronary revascularization in the recent 6 months. * Taking calcium channel blocker for the purpose of angina pectoris * Reduced ejection fraction (\< 40%) * Second- or third-degree of atrioventricular block * Severe hypertension (\> 200/110 mmHg) or secondary hypertension * History of stroke in the recent 6 months * Serum creatinine \> 2.5 mg/dl * Estimated survival duration less than 3 years due to other conditions * Pregnant woman or possibly pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite cardiovascular events including fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, admission due to heart failure, coronary intervention and sudden cardiac death | At least 3 years of mean follow up period |
Secondary
| Measure | Time frame |
|---|---|
| renal function | At least 3 years of mean follow up period |
| total death | At least 3 years of mean follow up period |
| cardiac function evaluated by ultrasonography | At least 3 years of mean follow up period |
| incidence of atrial fibrillation/flutter | At least 3 years of mean follow up period |
| control of blood glucose | At least 3 years of mean follow up period |
Countries
Japan
Outcome results
None listed