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NCT Number: NCT00126516

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

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.

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Key information

Conditions

Brain Infarction Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Hypertension Infarction Ischemia Mental Disorders Necrosis Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Department of Internal Medicine, Nara Medical University

Kashihara, Nara, 634-8522, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiotensin II Receptor Antagonists

Drug

any dosage, frequency, and duration

Angiotensin-converting Enzyme Inhibitors

Drug

any dosage, frequency, and duration

Primary outcomes

  1. Fatal and nonfatal stroke

    Time frame: two years

  2. Progression of silent brain infarction or white matter lesion on magnetic resonance imaging

    Time frame: two years

Secondary outcomes

  1. Fatal and nonfatal acute coronary syndrome

    Time frame: two years

  2. Admission for heart failure

    Time frame: two years

  3. All cause mortality

    Time frame: two years

Sponsors and collaborators

Lead sponsor

Nara Medical University

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Aug 4, 2005
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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