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

Primary Purpose

Brain Infarction, Hypertension

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Angiotensin II Receptor Antagonists

Angiotensin-converting Enzyme Inhibitors

About this trial

This is an interventional prevention trial for Brain Infarction focused on measuring silent brain infarction, cognitive decline, Angiotensin II Type 1 Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, hypertension

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

First Department of Internal Medicine, Nara Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Angiotensin II Receptor Antagonists group

Angiotensin-converting Enzyme Inhibitors group

Outcomes

Primary Outcome Measures

Fatal and nonfatal stroke

Progression of silent brain infarction or white matter lesion on magnetic resonance imaging

Secondary Outcome Measures

Fatal and nonfatal acute coronary syndrome

Admission for heart failure

All cause mortality

Full Information

NCT ID

NCT00126516

First Posted

August 3, 2005

Last Updated

October 28, 2013

Sponsor

Nara Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00126516

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nara Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Infarction, Hypertension

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

395 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Angiotensin II Receptor Antagonists group

Arm Title

Arm Type

Active Comparator

Arm Description

Angiotensin-converting Enzyme Inhibitors group

Intervention Type

Drug

Intervention Name(s)

Angiotensin II Receptor Antagonists

Intervention Description

any dosage, frequency, and duration

Intervention Type

Drug

Intervention Name(s)

Angiotensin-converting Enzyme Inhibitors

Intervention Description

any dosage, frequency, and duration

Primary Outcome Measure Information:

Title

Fatal and nonfatal stroke

Time Frame

two years

Title

Progression of silent brain infarction or white matter lesion on magnetic resonance imaging

Time Frame

two years

Secondary Outcome Measure Information:

Title

Fatal and nonfatal acute coronary syndrome

Time Frame

two years

Title

Admission for heart failure

Time Frame

two years

Title

All cause mortality

Time Frame

two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshihiko Saito, MD, PhD

Organizational Affiliation

First Department of Internal Medicine, Nara Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Department of Internal Medicine, Nara Medical University

City

Kashihara

State/Province

Nara

ZIP/Postal Code

634-8522

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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