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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- 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 ]
|Study Start Date:||December 2005|
|Study Completion Date:||December 2007|
|Active Comparator: 1||
iv. by weight (1.0 pmol/kg/min )
|Placebo Comparator: 2||
same rate of infusion as GLP-1
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.
|Afdeling B, Skejby Hospital|
|Aarhus, Denmark, 8200|
|Principal Investigator:||Hans Erik Bøtker, MD||Afdeling B, Skejby Hospital|