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Sponsors and Collaborators: |
Charite University, Berlin, Germany Bristol-Myers Squibb |
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Information provided by: | Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT00347087 |
To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves insulin sensitivity and metabolic profile in patients with chronic heart failure.
Condition | Intervention | Phase |
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Chronic Heart Failure |
Drug: Irbesartan |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of the Angiotensin II Receptor Antagonist Irbesartan on Insulin Sensitivity and Metabolic Profile in Patients With Chronic Heart Failure |
Enrollment: | 36 |
Study Start Date: | July 2004 |
Study Completion Date: | June 2007 |
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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Applied Cachexia Research, Cardiology Dept. Charite Medical School, Virchow Klinikum | |
Berlin, Germany |
Principal Investigator: | Wolfram Doehner, MD, PhD | Applied Cachexia Research, Cardiology, Charite, Campus Virchow Klinikum |
Study ID Numbers: | IRIS HF 7/04 |
Study First Received: | June 29, 2006 |
Last Updated: | October 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00347087 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Insulin sensitivity chronic heart failure metabolism |
Heart Failure Heart Diseases Irbesartan Angiotensin II Insulin |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Cardiovascular Diseases |
Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |