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

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GLP-1
placebo
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Chronic Congestive heart failure, Ischemic heart disease, insulin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Afdeling B, Skejby Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Effect on global left ventricular function
Effect on regional left ventricular function
Effect on exercise capacity
Effect on 6 minute walk test
Effect on insulin sensitivity
Effect on substrate metabolism at whole-body level and in the fore-arm

Secondary Outcome Measures

Full Information

First Posted
December 9, 2005
Last Updated
December 18, 2007
Sponsor
Aarhus University Hospital Skejby
Collaborators
University of Aarhus, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00264199
Brief Title
Effect of 48 Hours of Treatment With the Natural Peptide-Hormone GLP-1 in Patients With Chronic Heart Failure
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 Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
University of Aarhus, Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Chronic Congestive heart failure, Ischemic heart disease, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GLP-1
Intervention Description
iv. by weight (1.0 pmol/kg/min )
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
same rate of infusion as GLP-1
Primary Outcome Measure Information:
Title
Effect on global left ventricular function
Time Frame
at baseline and after 48 hours of intervention
Title
Effect on regional left ventricular function
Time Frame
at baseline and after 48 hours of intervention
Title
Effect on exercise capacity
Time Frame
at baseline and after 48 hours of intervention
Title
Effect on 6 minute walk test
Time Frame
at baseline and after 48 hours of intervention
Title
Effect on insulin sensitivity
Time Frame
after 48 hours of intervention
Title
Effect on substrate metabolism at whole-body level and in the fore-arm
Time Frame
after 48 hours of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Erik Bøtker, MD
Organizational Affiliation
Afdeling B, Skejby Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Afdeling B, Skejby Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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

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