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Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347087
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 31, 2007
Bristol-Myers Squibb
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Irbesartan Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Angiotensin II Receptor Antagonist Irbesartan on Insulin Sensitivity and Metabolic Profile in Patients With Chronic Heart Failure
Study Start Date : July 2004
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Irbesartan
    up-titration over 4 weeks to target dose 300 mg od

Primary Outcome Measures :
  1. Insulin sensitivity assessment using intravenous glucose tolerance testing [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Assessment of body composition using dual energy x-ray absorptiometry [ Time Frame: 3 months ]
  2. Assessment of exercise capacity on a treadmill including respiratory gas analysis [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347087

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Applied Cachexia Research, Cardiology Dept. Charite Medical School, Virchow Klinikum
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Bristol-Myers Squibb
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Principal Investigator: Wolfram Doehner, MD, PhD Applied Cachexia Research, Cardiology, Charite, Campus Virchow Klinikum

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00347087    
Other Study ID Numbers: IRIS HF 7/04
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by Charite University, Berlin, Germany:
Insulin sensitivity
chronic heart failure
Additional relevant MeSH terms:
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Heart Failure
Insulin Resistance
Heart Diseases
Cardiovascular Diseases
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action