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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00264199
Enrollment
20
Registered
2005-12-12
Start date
2005-12-31
Completion date
2007-12-31
Last updated
2007-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

Chronic Congestive heart failure, Ischemic heart disease, insulin resistance

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.

Interventions

DRUGGLP-1

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

DRUGplacebo

same rate of infusion as GLP-1

Sponsors

University of Aarhus
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Aarhus University Hospital Skejby
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Effect on global left ventricular functionat baseline and after 48 hours of intervention
Effect on regional left ventricular functionat baseline and after 48 hours of intervention
Effect on exercise capacityat baseline and after 48 hours of intervention
Effect on 6 minute walk testat baseline and after 48 hours of intervention
Effect on insulin sensitivityafter 48 hours of intervention
Effect on substrate metabolism at whole-body level and in the fore-armafter 48 hours of intervention

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026