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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Angiotensin II Receptor Antagonists group |
|
| 2 | Active Comparator | Angiotensin-converting Enzyme Inhibitors group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiotensin II Receptor Antagonists | Drug | any dosage, frequency, and duration |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fatal and nonfatal acute coronary syndrome | two years | |
| Admission for heart failure | two years | |
| All cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshihiko Saito, MD, PhD | First Department of Internal Medicine, Nara Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Department of Internal Medicine, Nara Medical University | Kashihara | Nara | 634-8522 | Japan |
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| Angiotensin-converting Enzyme Inhibitors |
| Drug |
any dosage, frequency, and duration |
|
| two years |
| ID | Term |
|---|---|
| D020520 | Brain Infarction |
| D006973 | Hypertension |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D057911 | Angiotensin Receptor Antagonists |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
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