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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ja

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 Summary:

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.


Sponsor: Nara Medical University

Current Primary Outcome:

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


Original Primary Outcome:

  • Fatal and nonfatal stroke
  • Progression of silent brain infarction
  • Cognitive decline


Current Secondary Outcome:

  • Fatal and nonfatal acute coronary syndrome [ Time Frame: two years ]
  • Admission for heart failure [ Time Frame: two years ]
  • All cause mortality [ Time Frame: two years ]


Original Secondary Outcome:

  • Progression of white matter lesion
  • Progression of brain atrophy
  • Progression of carotid atherosclerosis


Information By: Nara Medical University

Dates:
Date Received: August 3, 2005
Date Started: May 2004
Date Completion:
Last Updated: October 28, 2013
Last Verified: October 2013