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NCT Number: NCT00264199

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

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Hyperinsulinism Insulin Resistance Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afdeling B, Skejby Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic congestive heart failure
  • Ischemic heart disease

Exclusion criteria

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

Treatment and study plan

GLP-1

Drug

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

Placebo

Drug

same rate of infusion as GLP-1

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

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Aarhus University Hospital
  • University of Aarhus

Registry information

Official study title

The Effect of 48 Hours GLP-1 Infusion on Left Ventricular Function, Exercise Capacity, Insulin Sensitivity and Substrate Metabolism in Patients With Chronic Heart Failure

Important dates

Study start
2005
Study completion
2007
First posted
Dec 12, 2005
Registry last updated
Dec 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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