A Phase 4 interventional study of Irbesartan in Chronic Heart Failure, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2007-10-31.
Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Treatment
To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves insulin sensitivity and metabolic profile in patients with chronic heart failure.
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, i.e. 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.
2,025 studies on the registry are indexed under Insulin Resistance; 308 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 1,587 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
up-titration over 4 weeks to target dose 300 mg od
Insulin sensitivity assessment using intravenous glucose tolerance testing
Time frame: 3 months
Assessment of body composition using dual energy x-ray absorptiometry
Time frame: 3 months
Assessment of exercise capacity on a treadmill including respiratory gas analysis
Time frame: 3 months
This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Irbesartan
Charite University, Berlin, Germany →