Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To test whether treatment with the angiotensin II receptor antagonist Irbesartan improves insulin sensitivity and metabolic profile in patients with chronic heart failure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Bristol-Myers Squibb
• Treatments: Angiotensin Receptor Antagonists; Insulin; Irbesartan

Criteria

Inclusion Criteria:

1. ambulatory patients with symptomatic chronic heart failure (NAHY II-IV)

2. ischemic etiology

3. LVEF ≤ 45%

4. 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.

5. Patient should be hospitalised due to deterioration of the cardiac disease at least once in the last 12 months under ACE-I therapy.

6. age > 21 years

7. informed consent

Exclusion Criteria:

1. hospitalisation with intervention within 2 weeks of intended randomisation

2. unstable IHD or Myocardial infarction < 2 months

3. open diagnosed diabetes mellitus / antidiabetic treatment with insulin, metformin, sulfonylurea, glinides

4. COPD treated with steroids