Status:
COMPLETED
Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
21+ years
Phase:
PHASE4
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 skele...
Eligibility Criteria
Inclusion
- ambulatory patients with symptomatic chronic heart failure (NAHY II-IV)
- ischemic etiology
- LVEF ≤ 45%
- standard medical treatment for CHF (such as diuretics, beta blockers, ACE inhibitors, aspirin or warfarin). Patients should be treated with ACI inhibitor for at least 12 months prior to enrolment into the study. Patients should not be treated with angiotensin II receptor antagonists during the study other than the trial medication. Further medical treatment such as spironolactone, amiodarone and others are allowed if the patient is on a stable dose at the beginning of the trial. Dosages should be kept stable during the trial except adjustment is judged necessary for clinical reason.
- Patient should be hospitalised due to deterioration of the cardiac disease at least once in the last 12 months under ACE-I therapy.
- age \> 21 years
- informed consent
Exclusion
- hospitalisation with intervention within 2 weeks of intended randomisation
- unstable IHD or Myocardial infarction \< 2 months
- open diagnosed diabetes mellitus / antidiabetic treatment with insulin, metformin, sulfonylurea, glinides
- COPD treated with steroids
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00347087
Start Date
July 1 2004
End Date
June 1 2007
Last Update
October 31 2007
Active Locations (1)
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1
Applied Cachexia Research, Cardiology Dept. Charite Medical School, Virchow Klinikum
Berlin, Germany