Comparison of Valsartan With Amlodipine in Hypertensive Patients With Glucose Intolerance

Study Overview
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Brief Summary
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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.

Official Title
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The Novel Antihypertensive Goal Of hYpertension With diAbetes - Hypertensive Events and ARb Treatment (NAGOYA-HEART) Study

Conditions
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Hypertension, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Valsartan
* Drug: Amlodipine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Valsartan<br>Valsartan group treated with 80-160mg daily valsartan without Ca channel blockers or ACE inhibitors. | Drug: Valsartan<br>* valsartan 80 to 160 mg daily<br>|
| Active Comparator: Amlodipine<br>Amlodipine group treated with 5-10mg daily amlodipine without ACE inhibitors or angiotensin receptor blockers. | Drug: Amlodipine<br>* Amlodipine 5 to 10 mg daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| renal function |  | At least 3 years of mean follow up period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, rennin-angiotensin system, calcium channel blocker, impaired glucose tolerance