|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Skejby Hospital University of Aarhus Aarhus University Hospital |
|---|---|
| Information provided by: | Skejby Hospital |
| ClinicalTrials.gov Identifier: | NCT00264199 |
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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study |
| 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 |
| Enrollment: | 20 |
| Study Start Date: | December 2005 |
| Study Completion Date: | December 2007 |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: GLP-1
iv. by weight (1.0 pmol/kg/min )
|
| 2: Placebo Comparator |
Drug: placebo
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Afdeling B, Skejby Hospital | |
| Aarhus, Denmark, 8200 | |
| Principal Investigator: | Hans Erik Bøtker, MD | Afdeling B, Skejby Hospital |
More Information
| Responsible Party: | Aarhus University Hospital, Skejby ( Mads Halbirk ) |
| Study ID Numbers: | 20050048 |
| Study First Received: | December 9, 2005 |
| Last Updated: | December 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00264199 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
|
Chronic Congestive heart failure Ischemic heart disease insulin resistance |
|
Heart Failure Heart Diseases Myocardial Ischemia Ischemia |
Insulin Resistance Insulin Glucagon-Like Peptide 1 |
|
Cardiovascular Diseases |
