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

NCT ID: NCT00264199

Last Updated: 2007-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure, Congestive

Keywords

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Chronic Congestive heart failure Ischemic heart disease insulin resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

GLP-1

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

same rate of infusion as GLP-1

Interventions

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GLP-1

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

Intervention Type DRUG

placebo

same rate of infusion as GLP-1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital Skejby

OTHER

Sponsor Role lead

Responsible Party

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Aarhus University Hospital, Skejby

Principal Investigators

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Hans Erik Bøtker, MD

Role: PRINCIPAL_INVESTIGATOR

Afdeling B, Skejby Hospital

Locations

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Afdeling B, Skejby Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20050048

Identifier Type: -

Identifier Source: org_study_id