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

Heart Failure, Congestive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264199
• Other study ID #: 20050048
• Status: Completed
• Phase: N/A
• First received: December 9, 2005
• Last updated: December 18, 2007
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• GLP-1
iv. by weight (1.0 pmol/kg/min )
• placebo
same rate of infusion as GLP-1

Locations

Country	Name	City	State
Denmark	Afdeling B, Skejby Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Aarhus University Hospital, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on global left ventricular function		at baseline and after 48 hours of intervention
Primary	Effect on regional left ventricular function		at baseline and after 48 hours of intervention
Primary	Effect on exercise capacity		at baseline and after 48 hours of intervention
Primary	Effect on 6 minute walk test		at baseline and after 48 hours of intervention
Primary	Effect on insulin sensitivity		after 48 hours of intervention
Primary	Effect on substrate metabolism at whole-body level and in the fore-arm		after 48 hours of intervention