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

Sponsor

Aarhus University Hospital Skejby (Other)

Overall Status

Completed

CT.gov ID

NCT00264199

Collaborator

University of Aarhus (Other), Aarhus University Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive	Drug: GLP-1 Drug: placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Drug: GLP-1

iv. by weight (1.0 pmol/kg/min )

Placebo Comparator: 2

Drug: placebo

same rate of infusion as GLP-1

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Afdeling B, Skejby Hospital	Aarhus		Denmark	8200

Sponsors and Collaborators

Aarhus University Hospital Skejby
University of Aarhus
Aarhus University Hospital

Investigators

Principal Investigator: Hans Erik Bøtker, MD, Afdeling B, Skejby Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00264199

Other Study ID Numbers:

20050048

First Posted:

Dec 12, 2005

Last Update Posted:

Dec 27, 2007

Last Verified:

Dec 1, 2007

Keywords provided by , ,

Chronic Congestive heart failure

Ischemic heart disease

insulin resistance

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Dec 27, 2007