Viewing Study NCT00347087



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Study NCT ID: NCT00347087
Status: COMPLETED
Last Update Posted: 2007-10-31
First Post: 2006-06-29

Brief Title: Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure
Sponsor: Charite University Berlin Germany
Organization: Charite University Berlin Germany

Study Overview

Official Title: Effect of the Angiotensin II Receptor Antagonist Irbesartan on Insulin Sensitivity and Metabolic Profile in Patients With Chronic Heart Failure
Status: COMPLETED
Status Verified Date: 2007-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves insulin sensitivity and metabolic profile in patients with chronic heart failure
Detailed Description: In CHF impaired insulin sensitivity is a common finding characterised by elevated fasting insulin levels and impaired effectiveness of insulin to utilise glucose in peripheral tissues mainly in skeletal muscle tissue Additionally impaired insulin sensitivity ie insulin resistance progresses in parallel to severity of CHF and relates to major clinical symptoms such as reduced exercise capacity and muscle fatigue In survival analyses insulin resistance is a significant predictor of mortality independently of and additionally to other established prognostic markers such as age NYHA class peak oxygen consumption or LVEF These findings indicate that insulin resistance is involved in CHF pathophysiology Importantly insulin resistance in CHF occurs independently of ischemic etiology In ischaemic heart disease however insulin resistance as part of the metabolic syndrome is also an important prerequisite for the development of arteriosclerosis Accordingly insulin resistance was found worst in CHF patients with ischemic etiology compared to patients with CHF due to dilated cardiomyopathy and those with ischaemic heart disease without heart failure On the basis of these findings we hypothesise that therapeutically improving insulin sensitivity may have additional beneficial effects on energy utilisation and therefore improve clinical symptoms such as reduced exercise capacity and muscle fatigue

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None