Heart Failure, CongestiveNCT00264199
Effect of 48 Hours of Treatment With the Natural Peptide-Hormone GLP-1 in Patients With Chronic Heart Failure
A study testing GLP-1 in people with Heart Failure, Congestive, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive
- What is being tested?
- GLP-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2005to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic congestive heart failure
- Ischemic heart disease
Who cannot join
- Diabetes
- Exercise limiting disease other than heart failure
- Congenital heart disease
- Arterio-venous shunts
- Renal failure
- Valvular heart disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Congestive
- Being tested
- GLP-1, placebo
- Keywords
- Chronic Congestive heart failure, Ischemic heart disease, insulin resistance
- Medical subject headings
- Heart Failure, Myocardial Ischemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
iv. by weight (1.0 pmol/kg/min )
placeboDrug
same rate of infusion as GLP-1
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: GLP-1 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on global left ventricular function
Measured: at baseline and after 48 hours of intervention
Effect on regional left ventricular function
Measured: at baseline and after 48 hours of intervention
Effect on exercise capacity
Measured: at baseline and after 48 hours of intervention
Effect on 6 minute walk test
Measured: at baseline and after 48 hours of intervention
Effect on insulin sensitivity
Measured: after 48 hours of intervention
Effect on substrate metabolism at whole-body level and in the fore-arm
Measured: after 48 hours of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startDec 2005
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Investigators
- Hans Erik Bøtker, MD, Principal investigator, Afdeling B, Skejby Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264199
- Sponsor's protocol ID
- 20050048
- Status last verified
- Dec 2007
- First submitted
- 9 Dec 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00264199
- Acronym / sponsor ID
- 20050048
- Conditions
- Heart Failure, Congestive
- Keywords
- Chronic Congestive heart failure, Ischemic heart disease, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital
- Study start
- Dec 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GLP-1 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic congestive heart failure
- Ischemic heart disease
Key exclusion criteria (6 listed)
- Diabetes
- Exercise limiting disease other than heart failure
- Congenital heart disease
- Arterio-venous shunts
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1iv. by weight (1.0 pmol/kg/min ) | Drug | 1 |
| placebosame rate of infusion as GLP-1 | Drug | 2 |
Primary outcome
Effect on global left ventricular function
Time frame: at baseline and after 48 hours of intervention
Effect on regional left ventricular function
Time frame: at baseline and after 48 hours of intervention
Effect on exercise capacity
Time frame: at baseline and after 48 hours of intervention
Effect on 6 minute walk test
Time frame: at baseline and after 48 hours of intervention
Effect on insulin sensitivity
Time frame: after 48 hours of intervention
Effect on substrate metabolism at whole-body level and in the fore-arm
Time frame: after 48 hours of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Erik Bøtker, MD principal investigator
Afdeling B, Skejby Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 in people with Heart Failure, Congestive, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on global left ventricular function (time frame: at baseline and after 48 hours of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2007.