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

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Angiotensin II Receptor Antagonists Drug
    Intervention Desc: any dosage, frequency, and duration
    ARM 1: Kind: Experimental
    Label: 1
    Description: Angiotensin II Receptor Antagonists group
  • Angiotensin-converting Enzyme Inhibitors Drug
    Intervention Desc: any dosage, frequency, and duration
    ARM 1: Kind: Experimental
    Label: 2
    Description: Angiotensin-converting Enzyme Inhibitors group

Trial Design

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

Outcomes

Type Measure 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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