Effect of 48 Hours of Treatment With the Natural Peptide-... | NCT00264199

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

NCT00264199

Sponsor

Aarhus University Hospital Skejby

Status

Completed

Last Update Posted

Dec 27, 2007Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Heart Failure, Congestive

Interventions

GLP-1
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

Dec 9, 2005

First Submission Date that Met QC Criteria

Dec 9, 2005

First Posted Date

Dec 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2007

Last Update Posted Date

Dec 27, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Aarhus University Hospital SkejbyOTHER

Collaborators

Name	Class
University of Aarhus	OTHER
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: GLP-1
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLP-1	Drug	iv. by weight (1.0 pmol/kg/min )	1
placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Erik Bøtker, MD	Afdeling B, Skejby Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Afdeling B, Skejby Hospital		Aarhus		8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D017202	Myocardial Ischemia
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D052216	Glucagon-Like Peptide 1

Ancestor Terms

ID	Term
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided