Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

NCT00347087 | Completed Phase 4

• 1 other identifier: IRIS HF 7/04
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Keywords

Insulin sensitivity; chronic heart failure; metabolism

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity assessment using intravenous glucose tolerance testing

  3 months

Secondary Outcomes (2)

• Assessment of body composition using dual energy x-ray absorptiometry

  3 months

• Assessment of exercise capacity on a treadmill including respiratory gas analysis

  3 months

Interventions

Irbesartan DRUG

up-titration over 4 weeks to target dose 300 mg od

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Applied Cachexia Research, Cardiology Dept. Charite Medical School, Virchow Klinikum

Berlin, Germany

Location

Related Publications (1)

• Doehner W, Todorovic J, Kennecke C, Rauchhaus M, Sandek A, Lainscak M, van Linthout S, Tschope 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.

  PMID: 21856022 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Wolfram Doehner, MD, PhD

  Applied Cachexia Research, Cardiology, Charite, Campus Virchow Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2006
• First Posted: July 4, 2006
• Study Start: July 1, 2004
• Study Completion: June 1, 2007
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

DE (1)