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
Overview
- Phase
- Phase 3
- Intervention
- Irbesartan
- Conditions
- Hypercholesterolemia
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
see above
Investigators
Roland E. Schmieder
Prof. Dr. med.
University of Erlangen-Nürnberg Medical School
Eligibility 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.
Arms & Interventions
Irbesartan
Intervention: Irbesartan
Placebo
Intervention: Irbesartan
Outcomes
Primary Outcomes
Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects
Secondary Outcomes
- Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients