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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00264199
First Posted: December 12, 2005
Last Update Posted: December 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Aarhus
Aarhus University Hospital
Information provided by:
Aarhus University Hospital Skejby
  Purpose
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.

Condition Intervention
Heart Failure, Congestive Drug: GLP-1 Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Effect on global left ventricular function [ Time Frame: at baseline and after 48 hours of intervention ]
  • Effect on regional left ventricular function [ Time Frame: at baseline and after 48 hours of intervention ]
  • Effect on exercise capacity [ Time Frame: at baseline and after 48 hours of intervention ]
  • Effect on 6 minute walk test [ Time Frame: at baseline and after 48 hours of intervention ]
  • Effect on insulin sensitivity [ Time Frame: after 48 hours of intervention ]
  • Effect on substrate metabolism at whole-body level and in the fore-arm [ Time Frame: after 48 hours of intervention ]

Enrollment: 20
Study Start Date: December 2005
Study Completion Date: December 2007
Arms Assigned Interventions
Active Comparator: 1 Drug: GLP-1
iv. by weight (1.0 pmol/kg/min )
Placebo Comparator: 2 Drug: placebo
same rate of infusion as GLP-1

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264199


Locations
Denmark
Afdeling B, Skejby Hospital
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Hans Erik Bøtker, MD Afdeling B, Skejby Hospital
  More Information

Responsible Party: Mads Halbirk, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier: NCT00264199     History of Changes
Other Study ID Numbers: 20050048
First Submitted: December 9, 2005
First Posted: December 12, 2005
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Aarhus University Hospital Skejby:
Chronic Congestive heart failure
Ischemic heart disease
insulin resistance

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents