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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00126516

Enrollment

395

Registered

2005-08-04

Start date

2004-05-31

Completion date

2013-06-30

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Infarction, Hypertension

Keywords

silent brain infarction, cognitive decline, Angiotensin II Type 1 Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, hypertension

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.

Interventions

DRUGAngiotensin II Receptor Antagonists

any dosage, frequency, and duration

DRUGAngiotensin-converting Enzyme Inhibitors

any dosage, frequency, and duration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Fatal and nonfatal stroke	two years
Progression of silent brain infarction or white matter lesion on magnetic resonance imaging	two years

Secondary

Measure	Time frame
Fatal and nonfatal acute coronary syndrome	two years
Admission for heart failure	two years
All cause mortality	two years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026