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

October 28, 2013 updated by: Yoshihiko Saito, Nara Medical University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

395

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • First Department of Internal Medicine, Nara Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yoshihiko Saito, MD, PhD, First Department of Internal Medicine, Nara Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

August 3, 2005

First Submitted That Met QC Criteria

August 3, 2005

First Posted (Estimate)

August 4, 2005

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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