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

Not Applicable

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Drug: GLP-1; Drug: placebo

• Registration Number: NCT00264199
• Lead Sponsor: Aarhus University Hospital Skejby

Brief 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.

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-09
• Study First Submitted QC: 2005-12-09
• Study First Posted: 2005-12-12
• Status Verified: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2007-12-18
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	GLP-1	-
2	placebo	-

Primary Outcome Measures

Name	Time	Method
Effect on global left ventricular function	at baseline and after 48 hours of intervention
Effect on regional left ventricular function	at baseline and after 48 hours of intervention
Effect on exercise capacity	at baseline and after 48 hours of intervention
Effect on 6 minute walk test	at baseline and after 48 hours of intervention
Effect on insulin sensitivity	after 48 hours of intervention
Effect on substrate metabolism at whole-body level and in the fore-arm	after 48 hours of intervention

Trial Locations

Locations (1)

Afdeling B, Skejby Hospital; 🇩🇰 Aarhus, Denmark