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

Phase 4

Completed

• Conditions: Brain Infarction; Hypertension
• Interventions: Drug: Angiotensin II Receptor Antagonists; Drug: Angiotensin-converting Enzyme Inhibitors

• Registration Number: NCT00126516
• Lead Sponsor: Nara Medical University

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.

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Angiotensin II Receptor Antagonists	Angiotensin II Receptor Antagonists group
2	Angiotensin-converting Enzyme Inhibitors	Angiotensin-converting Enzyme Inhibitors group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Department of Internal Medicine, Nara Medical University; 🇯🇵 Kashihara, Nara, Japan