Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia - Full Text View

Purpose

The retinal vasculature is morphologically and functionally related to the cerebral vessels due to its common origin from the internal carotid artery. A recent study demonstrated that endothelium-dependent vasodilation of the retinal vasculature is impaired in patients with essential hypertension, which is a strong risk factor for stroke. Furthermore, AT1-receptor blockade was demonstrated to improve retinal endothelium-dependent vasodilation in these hypertensive patients. Hypercholesterolemia is also a risk factor for ischemic stroke and impairment of endothelial function has been observed in various vascular beds in hypercholesterolemic patients, including the coronary and the forearm vasculature. Whether endothelial function of the retinal vasculature is impaired in patients with hypercholesterolemia has not yet been investigated. In patients with stroke, AT1-receptor blockade and angiotensin-converting enzyme inhibition have beneficial effects on clinical outcome. Alterations of endothelial function of the cerebral vasculature might be one pathogenetic factor for the beneficial clinical outcome. To further address this issue, the present study was designed to test the hypothesis that endothelium-dependent vasodilation of the retinal vasculature is impaired in hypercholesterolemic patients and that endothelial function can be improved by AT1-receptor blockade.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Irbesartan	Phase III

Genetics Home Reference related topics:

hypercholesterolemia

MedlinePlus related topics:

Ataxia Telangiectasia Cholesterol High Blood Pressure

ChemIDplus related topics:

Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	A Randomised, Double-Blind, Placebo-Controlled, Phase III Trial to Study the Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia

Further study details as provided by University of Erlangen-Nürnberg:

Primary Outcome Measures:

Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects

Secondary Outcome Measures:

Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients

Estimated Enrollment:	80
Estimated Study Completion Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male patients aged 18-65 years with LDL-cholesterol >= 130mg/dl
Male healthy control subjects aged 18-65 years

Exclusion Criteria:

All kinds of secondary hyperlipidemia.
Advanced damage of vital organs (grades III and IV retinopathy)
Lipid-lowering drugs (including lipid lowering dietary supplements or food additives) within the last 4 weeks
History of serious hypersensitivity reaction to AT1-receptor blockers
Actual or anamnestic alcohol- or drug abuse.
Smokers or ex-smokers < 1 year.
Patients with Diabetes mellitus (oral medication or insulin).
Patients with arterial fibrillation or AV-Block (II° or more).
Patients with anamnestic myocardial infarction.
Patients with instable angina pectoris including EcG-aberrations or cardiac insufficiency NYHA III or IV.
History of malignancy (unless a documented disease-free period exceeding 10 years is present) with the exception of basal cell carcinoma of the skin
History of allograft transplantation
Patients with anaphylaxis or known therapy resistance of the used test matters
Therapy with not approved concomitant medication, or participation in a clinical study within 4 weeks preceding treatment start.
Disease which interfere with the pharmacodynamics and pharmacokinetics of the study drug.
Liver or kidney disease with SGOT, GPT, g-GT, AP, bilirubin and creatinin above 200% of standard.
Patients, who are not sufficiently compliant, or patients, who are not capable or willing to appear for controlling visits.
Presumed risk of transmission of HIV or hepatitis via blood from the proband

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152698

Locations


Germany, Bavaria
	CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg
	Erlangen, Bavaria, Germany, 91054

Sponsors and Collaborators

University of Erlangen-Nürnberg

Bristol-Myers Squibb

Investigators


Principal Investigator:	Roland E Schmieder, MD	CRC, Medizinische Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg

More Information

Study ID Numbers:	Retina-Irbesartan
First Received:	September 8, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00152698
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Metabolic Diseases

Hyperlipidemias

Irbesartan

Angiotensin II

Metabolic disorder

Hypercholesterolemia

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	University of Erlangen-Nürnberg Bristol-Myers Squibb
Information provided by:	University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier:	NCT00152698