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

NCT ID: NCT00126516

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Infarction Hypertension

Keywords

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silent brain infarction cognitive decline Angiotensin II Type 1 Receptor Blockers Angiotensin-Converting Enzyme Inhibitors hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Angiotensin II Receptor Antagonists group

Group Type ACTIVE_COMPARATOR

Angiotensin II Receptor Antagonists

Intervention Type DRUG

any dosage, frequency, and duration

2

Angiotensin-converting Enzyme Inhibitors group

Group Type ACTIVE_COMPARATOR

Angiotensin-converting Enzyme Inhibitors

Intervention Type DRUG

any dosage, frequency, and duration

Interventions

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Angiotensin II Receptor Antagonists

any dosage, frequency, and duration

Intervention Type DRUG

Angiotensin-converting Enzyme Inhibitors

any dosage, frequency, and duration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nara Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yoshihiko Saito

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoshihiko Saito, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Department of Internal Medicine, Nara Medical University

Locations

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First Department of Internal Medicine, Nara Medical University

Kashihara, Nara, Japan

Site Status

Countries

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Japan

Other Identifiers

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03-Ken-52

Identifier Type: -

Identifier Source: org_study_id