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

Purpose

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.

Condition	Intervention	Phase
Brain Infarction Hypertension	Drug: Angiotensin II Receptor Antagonists Drug: Angiotensin-converting Enzyme Inhibitors	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Nara Medical University:

Primary Outcome Measures:

Fatal and nonfatal stroke [ Time Frame: two years ] [ Designated as safety issue: No ]
Progression of silent brain infarction or white matter lesion on magnetic resonance imaging [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fatal and nonfatal acute coronary syndrome [ Time Frame: two years ] [ Designated as safety issue: No ]
Admission for heart failure [ Time Frame: two years ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]


Enrollment:	395
Study Start Date:	May 2004
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Angiotensin II Receptor Antagonists group	Drug: Angiotensin II Receptor Antagonists any dosage, frequency, and duration
Active Comparator: 2 Angiotensin-converting Enzyme Inhibitors group	Drug: Angiotensin-converting Enzyme Inhibitors any dosage, frequency, and duration

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


Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126516

Locations


Japan
First Department of Internal Medicine, Nara Medical University
Kashihara, Nara, Japan, 634-8522

Sponsors and Collaborators

Nara Medical University

Investigators


Principal Investigator:	Yoshihiko Saito, MD, PhD	First Department of Internal Medicine, Nara Medical University

More Information

No publications provided


Responsible Party:	Yoshihiko Saito, Professor, Nara Medical University
ClinicalTrials.gov Identifier:	NCT00126516 History of Changes
Other Study ID Numbers:	03-Ken-52
Study First Received:	August 3, 2005
Last Updated:	October 28, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nara Medical University:


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

Additional relevant MeSH terms:


Brain Infarction Hypertension Infarction Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Necrosis Nervous System Diseases Pathologic Processes	Stroke Vascular Diseases Angiotensin II Angiotensin Receptor Antagonists Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 01, 2015