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CompletedNCT00347087Updated Oct 31, 2007

Effect of Irbesartan on Insulin Sensitivity in Chronic Heart Failure

A Phase 4 interventional study of Irbesartan in Chronic Heart Failure, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2007-10-31.

Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Heart Failure

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Keywords

  • Insulin sensitivity
  • chronic heart failure
  • metabolism
03

In context

Insulin Resistance

2,025 studies on the registry are indexed under Insulin Resistance; 308 are open to participants now.

This study's enrollment of 36 is close to the median of 40 across 1,587 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 854 studies on the registry; 127 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Interventions

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

06

What researchers measure

Primary outcomes

  1. Insulin sensitivity assessment using intravenous glucose tolerance testing

    Time frame: 3 months

Secondary outcomes

  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

07

Study locations

1 site
  • Applied Cachexia Research, Cardiology Dept. Charite Medical School, Virchow Klinikum
    Berlin, Germany
08

References and documents

Publications

  • 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. PubMed 21856022 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00347087
First posted
Jul 4, 2006
Start date
Jul 2004
Completion
Jun 2007
Last update
Oct 31, 2007

Study contacts

Wolfram Doehner, MD, PhD
principal investigator · Applied Cachexia Research, Cardiology, Charite, Campus Virchow Klinikum
View the source record on ClinicalTrials.gov ↗

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