Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00347087
• Date of registration: 29/06/2006
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure
• Scientific title: Effect of the Angiotensin II Receptor Antagonist Irbesartan on Insulin Sensitivity and Metabolic Profile in Patients With Chronic Heart Failure
• Date of first enrolment: July 2004
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00347087
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Germany

Contacts

• Name: Wolfram Doehner, MD, PhD
• Affiliation: Applied Cachexia Research, Cardiology, Charite, Campus Virchow Klinikum

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Heart Failure

Intervention(s)

Drug: Irbesartan

Primary Outcome(s)

Insulin sensitivity assessment using intravenous glucose tolerance testing [Time Frame: 3 months]

Secondary Outcome(s)

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]

Secondary ID(s)

IRIS HF 7/04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb