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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshihiko Saito, Nara Medical University
ClinicalTrials.gov Identifier:
NCT00126516
First received: August 3, 2005
Last updated: October 28, 2013
Last verified: October 2013
  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:


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:
Infarction
Hypertension
Cognition Disorders
Brain Infarction
Ischemia
Pathologic Processes
Necrosis
Vascular Diseases
Cardiovascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Enzyme Inhibitors
Angiotensin-Converting Enzyme Inhibitors
Angiotensin II
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 02, 2014