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CompletedNCT00264199Updated Dec 27, 2007

Effect of 48 Hours of Treatment With the Natural Peptide-Hormone GLP-1 in Patients With Chronic Heart Failure

An interventional study of GLP-1 and placebo in Heart Failure, Congestive, sponsored by Aarhus University Hospital Skejby. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-27.

Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether 48 hours of glucagon-like-peptide-1 (GLP-1) infusion can improve heart function and alter substrate metabolism in non-diabetic patients with heart failure.

Read the detailed description

Heart failure is a major complication in patients with ischemic heart disease. It has been shown that many of these patients have areas of viable myocardium that are not effectively contributing to heart function.

Further, chronic congestive heart failure is associated with some degree of insulin resistance in both skeletal and cardiac muscle.

GLP-1 is a naturally occurring peptide hormone that acts as an incretin and has been intensively studied by many groups in association with type II diabetes and it has clearly shown its glucose lowering potential with very little risk of hypoglycemia in several trials.

Recently GLP-1 has been shown to improve cardiac function in dogs with pace-induced cardiomyopathy, and in an open-labeled study it did improve cardiac function in patients with acute myocardial infarctions.

Comparison: 48 hours of treatment with intravenous GLP-1 compared to placebo. Effect on global and regional left ventricular function, exercise capacity, insulin sensitivity and substrate metabolism.

02

Conditions studied

  • Heart Failure, Congestive

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Keywords

  • Chronic Congestive heart failure
  • Ischemic heart disease
  • insulin resistance
03

In context

Heart Failure

5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 20 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • Chronic congestive heart failure
  • Ischemic heart disease

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • Exercise limiting disease other than heart failure
  • Congenital heart disease
  • Arterio-venous shunts
  • Renal failure
  • Valvular heart disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    1

    Drug: GLP-1

  • Placebo comparator
    2

    Drug: placebo

Interventions

  • DrugGLP-1

    iv. by weight (1.0 pmol/kg/min )

  • Drugplacebo

    same rate of infusion as GLP-1

06

What researchers measure

Primary outcomes

  1. Effect on global left ventricular function

    Time frame: at baseline and after 48 hours of intervention

  2. Effect on regional left ventricular function

    Time frame: at baseline and after 48 hours of intervention

  3. Effect on exercise capacity

    Time frame: at baseline and after 48 hours of intervention

  4. Effect on 6 minute walk test

    Time frame: at baseline and after 48 hours of intervention

  5. Effect on insulin sensitivity

    Time frame: after 48 hours of intervention

  6. Effect on substrate metabolism at whole-body level and in the fore-arm

    Time frame: after 48 hours of intervention

07

Study locations

1 site
  • Afdeling B, Skejby Hospital
    Aarhus, 8200, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00264199
Lead sponsor
Aarhus University Hospital Skejby
Collaborators
University of Aarhus, Aarhus University Hospital
First posted
Dec 12, 2005
Start date
Dec 2005
Completion
Dec 2007
Last update
Dec 27, 2007

Study contacts

Hans Erik Bøtker, MD
principal investigator · Afdeling B, Skejby Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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