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NCT00126516 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00126516
Other study ID # 03-Ken-52
Secondary ID
Status Completed
Phase Phase 4
First received August 3, 2005
Last updated October 28, 2013
Start date May 2004
Est. completion date June 2013

Study information
Verified date October 2013
Source Nara Medical University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 395
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Angiotensin II Receptor Antagonists
any dosage, frequency, and duration
• Angiotensin-converting Enzyme Inhibitors
any dosage, frequency, and duration

Locations
Country Name City State
Japan First Department of Internal Medicine, Nara Medical University Kashihara Nara

Sponsors (1)
Lead Sponsor Collaborator
Nara Medical University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fatal and nonfatal stroke two years No
Primary Progression of silent brain infarction or white matter lesion on magnetic resonance imaging two years No
Secondary Fatal and nonfatal acute coronary syndrome two years No
Secondary Admission for heart failure two years No
Secondary All cause mortality two years No
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