Effect of Irbesartan on Endothelial Function of the Retinal Vasculature in Patients With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152698
• Other study ID #: Retina-Irbesartan
• Status: Completed
• Phase: Phase 3
• Start date: November 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Irbesartan

Locations

Country	Name	City	State
Germany	CRC, Medizinsiche Klinik 4, Nephrology and Hypertension, University of Erlangen-Nürnberg	Erlangen	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of retinal endothelial function between hypercholesterolemic patients and healthy control subjects
Secondary	Effect of AT1-receptor blockade on retinal endothelial function in hypercholesterolemic patients