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

Nara Medical University

Status and phase: Completed; Phase 4

Conditions: Hypertension; Brain Infarction

Treatments: Drug: Angiotensin II Receptor Antagonists; Drug: Angiotensin-converting Enzyme Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT00126516

03-Ken-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 395 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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395 participants in 2 patient groups

1

Active Comparator group

Description:

Angiotensin II Receptor Antagonists group

Treatment:

Drug: Angiotensin II Receptor Antagonists

2

Active Comparator group

Description:

Angiotensin-converting Enzyme Inhibitors group

Treatment:

Drug: Angiotensin-converting Enzyme Inhibitors