Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.

Detailed Description
-----------------
Hypertension plays a major role in the development of cardiovascular diseases. Treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. Angiotensin converting enzyme inhibitor (ACEI), ramipril, showed a 32 % in relative risk of reduction in the Heart Outcomes Prevention Evaluation (HOPE) trial. Angiotensin II receptor blocker (ARB), losartan, also showed a 25 % in relative risk of reduction in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE). Elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. However, no reports are seen on comparison of the effects of ARBs and ACEIs on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly. The researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by Mini-Mental State Examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by ARB or ACEI.

Official Title
-----------------
Effects of Angiotensin II Receptor Blockers (ARB) and Angiotensin Converting Enzyme Inhibitors (ACEI) on Progression of Silent Brain Infarction and Cognitive Decline in Japanese Patients With Essential Hypertension in the Elderly

Conditions
-----------------
Brain Infarction, Hypertension

Intervention / Treatment
-----------------
* Drug: Angiotensin II Receptor Antagonists
* Drug: Angiotensin-converting Enzyme Inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs) Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging Exclusion Criteria: Secondary hypertension Atrial fibrillation History or signs of cerebral disorders other than cerebrovascular disease Malignant tumor Chronic renal failure Severe congestive heart failure Hyperkalemia Stenosis of bilateral renal artery

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Angiotensin II Receptor Antagonists group | Drug: Angiotensin II Receptor Antagonists<br>* any dosage, frequency, and duration<br>|
| Active Comparator: 2<br>Angiotensin-converting Enzyme Inhibitors group | Drug: Angiotensin-converting Enzyme Inhibitors<br>* any dosage, frequency, and duration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatal and nonfatal stroke |  | two years | 
| Progression of silent brain infarction or white matter lesion on magnetic resonance imaging |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatal and nonfatal acute coronary syndrome |  | two years | 
| Admission for heart failure |  | two years | 
| All cause mortality |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
silent brain infarction, cognitive decline, Angiotensin II Type 1 Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, hypertension