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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Drug: GLP-1
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: GLP-1<br>* iv. by weight (1.0 pmol/kg/min )<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* same rate of infusion as GLP-1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Congestive heart failure, Ischemic heart disease, insulin resistance