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Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT00347087
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE June 29, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date October 31, 2007
Study Start Date  ICMJE July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
Insulin sensitivity assessment using intravenous glucose tolerance testing [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
Insulin sensitivity assessment using intravenous glucose tolerance testing
Change History Complete list of historical versions of study NCT00347087 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2006)
  • Assessment of peripheral blood flow and endothelial function
  • Assessment of body composition using dual energy x-ray absorptiometry
  • Assessment of exercise capacity on a treadmill including respiratory gas analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure
Official Title  ICMJE Effect of the Angiotensin II Receptor Antagonist Irbesartan on Insulin Sensitivity and Metabolic Profile in Patients With Chronic Heart Failure
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Heart Failure
Intervention  ICMJE Drug: Irbesartan
up-titration over 4 weeks to target dose 300 mg od
Study Arms  ICMJE Not Provided
Publications * Doehner W, Todorovic J, Kennecke C, Rauchhaus M, Sandek A, Lainscak M, van Linthout S, Tschöpe C, von Haehling S, Anker SD. Improved insulin sensitivity by the angiotensin receptor antagonist irbesartan in patients with systolic heart failure: a randomized double-blinded placebo-controlled study. Int J Cardiol. 2012 Nov 29;161(3):137-42. doi: 10.1016/j.ijcard.2011.07.051.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2006)
36
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347087
Other Study ID Numbers  ICMJE IRIS HF 7/04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Wolfram Doehner, MD, PhD Applied Cachexia Research, Cardiology, Charite, Campus Virchow Klinikum
PRS Account Charite University, Berlin, Germany
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP