Clinical trial NCT00126516: Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Infarction
Hypertension
Keywords: silent brain infarction
cognitive decline
Angiotensin II Type 1 Receptor Blockers
Angiotensin-Converting Enzyme Inhibitors
hypertension
Lead sponsor: Nara Medical University
Sponsor class: OTHER
First posted: 2005-08-04
Enrollment: 395
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatal and nonfatal stroke
timeFrame: two years
measure: Progression of silent brain infarction or white matter lesion on magnetic resonance imaging
timeFrame: two years
Secondary outcomes:
measure: Fatal and nonfatal acute coronary syndrome
timeFrame: two years
measure: Admission for heart failure
timeFrame: two years
measure: All cause mortality
timeFrame: two years
Other outcomes:
Locations:
city: Kashihara
country: Japan
facility: First Department of Internal Medicine, Nara Medical University
state: Nara
Study officials:
affiliation: First Department of Internal Medicine, Nara Medical University
name: Yoshihiko Saito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: