NCT00264199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 27, 2007

Status Verified

December 1, 2007

First QC Date

December 9, 2005

Last Update Submit

December 18, 2007

Conditions

Heart Failure, Congestive

Keywords

Chronic Congestive heart failureIschemic heart diseaseinsulin resistance

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: GLP-1

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

GLP-1DRUG

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

1
placeboDRUG

same rate of infusion as GLP-1

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic congestive heart failure
  • Ischemic heart disease

You may not qualify if:

  • Diabetes
  • Exercise limiting disease other than heart failure
  • Congenital heart disease
  • Arterio-venous shunts
  • Renal failure
  • Valvular heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afdeling B, Skejby Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Heart FailureMyocardial IschemiaInsulin Resistance

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Hans Erik Bøtker, MD

    Afdeling B, Skejby Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

December 1, 2005

Study Completion

December 1, 2007

Last Updated

December 27, 2007

Record last verified: 2007-12

Locations

DK(1)