Clinical trial NCT00264199: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: Chronic Congestive heart failure
Ischemic heart disease
insulin resistance
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Aarhus University Hospital
First posted: 2005-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effect on global left ventricular function
timeFrame: at baseline and after 48 hours of intervention
measure: Effect on regional left ventricular function
timeFrame: at baseline and after 48 hours of intervention
measure: Effect on exercise capacity
timeFrame: at baseline and after 48 hours of intervention
measure: Effect on 6 minute walk test
timeFrame: at baseline and after 48 hours of intervention
measure: Effect on insulin sensitivity
timeFrame: after 48 hours of intervention
measure: Effect on substrate metabolism at whole-body level and in the fore-arm
timeFrame: after 48 hours of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Afdeling B, Skejby Hospital
Study officials:
affiliation: Afdeling B, Skejby Hospital
name: Hans Erik Bøtker, MD
role: PRINCIPAL_INVESTIGATOR
References: