Coronary Artery DiseasePhase 3ExecutiveNCT01373216
Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass
A Phase 3 study testing Exenatide in people with Coronary Artery Disease and Decreased Left Ventricular Function, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Decreased Left Ventricular Function
- What is being tested?
- Exenatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2011to Dec 2014
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective coronary artery bypass grafting operation (CABG)
- decreased left ventricular (LV) systolic function (EF LV ≤ 50%)
- Age 18 to 85
- Signed informed consent
- Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners)
Who cannot join
- allergy to exenatide
- allergy to insulin
- mental incapacity or language barrier
- use of incretin-based therapies <3 months before inclusion in the study
- diabetic ketoacidosis
- established autonomic neuropathy
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- history of acute pancreatitis or severe disease of digestive tract
- renal failure (preoperative creatinine ≥ 180 umol/l)
- liver failure (coagulation times more than 1.5 times higher without use of anticoagulants)
- cardiac surgical procedure on valve, thoracic aorta or MAZE procedure
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs
GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known. Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and glucose control in patients with coronary atherosclerosis and decreased left ventricular function undergoing elective coronary artery bypass grafting operation (CABG). In addition, safety and tolerability of peri-operative administration of exenatide in these patients will be examined as a secondary study objective.
- Being tested
- Exenatide
- Medical subject headings
- Coronary Artery Disease, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Perioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment Receives: Drug: Exenatide |
| Control | No intervention | Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function - echocardiographic parameters
- cardiac chamber dimensions
- left ventricular systolic function
- left ventricular diastolic function
- right ventricular systolic function
Measured: 90 days after administration of exenatide
Secondary outcomes (1)
Number of participants with adverse effects
Measured: 90 days after administration of exenatide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Martin Haluzik, Charles University, Czech Republic
- Investigators
- Martin Haluzik, D.Sc., Principal investigator, General University Hospital, Charles University, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373216
- Sponsor's protocol ID
- H8O-CY-O027
- Acronym
- Executive
- Status last verified
- Jan 2016
- First submitted
- 10 Jun 2011
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lips M, Mraz M, Klouckova J, Kopecky P, Dobias M, Krizova J, Lindner J, Diamant M, Haluzik M. Effect of continuous exenatide infusion on cardiac function and peri-operative glucose control in patients undergoing cardiac surgery: A single-blind, randomized controlled trial. Diabetes Obes Metab. 2017 Dec;19(12):1818-1822. doi: 10.1111/dom.13029. Epub 2017 Jul 31.
PubMed 28581209
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs
- ClinicalTrials.gov ID
- NCT01373216
- Acronym / sponsor ID
- Executive / H8O-CY-O027
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jun 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Jun 2011 (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.
GLP-1 has not only beneficial effects on glucose metabolism but also direct positive effects on cardiac function and metabolism in both experimental models and in patients with type 2 diabetes mellitus. Clinical data on the effects of GLP-1 agonists on cardiac function and glucose control in patients undergoing cardiac surgery are not known. Based on the results of experimental studies there is a potential for exenatide to positively influence both cardiac function and glucose metabolism in cardiac surgery patients with and without type 2 diabetes mellitus. The primary endpoint of this study is to examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhythmic and inotropic treatment and glucose control in patients with coronary atherosclerosis and decreased left ventricular function undergoing elective coronary artery bypass grafting operation (CABG). In addition, safety and tolerability of peri-operative administration of exenatide in these patients will be examined as a secondary study objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: ExenatidePatients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment |
| Control | No intervention | –Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving standard treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- elective coronary artery bypass grafting operation (CABG)
- decreased left ventricular (LV) systolic function (EF LV ≤ 50%)
- Age 18 to 85
- Signed informed consent
- Females with childbearing potential have to use appropriate contraceptive measures during the whole study period and 6 months after terminating exenatide infusion (hormonal contraception or double-barrier contraception for both partners)
Key exclusion criteria (11 listed)
- allergy to exenatide
- allergy to insulin
- mental incapacity or language barrier
- use of incretin-based therapies <3 months before inclusion in the study
- diabetic ketoacidosis
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 |
|---|---|---|
| ExenatidePerioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours | Drug | Exenatide |
Primary outcome
Cardiac function - echocardiographic parameters
Time frame: 90 days after administration of exenatide
* cardiac chamber dimensions * left ventricular systolic function * left ventricular diastolic function * right ventricular systolic function
1 secondary outcome
Number of participants with adverse effects
Time frame: 90 days after administration of exenatide
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 2 Feb 2016.
- Derived from this study: PubMed 28581209Lips M, Mraz M, Klouckova J, Kopecky P, Dobias M, Krizova J, Lindner J, Diamant M, Haluzik M. Effect of continuous exenatide infusion on cardiac function and peri-operative glucose control in patients undergoing cardiac surgery: A single-blind, randomized controlled trial. Diabetes Obes Metab. 2017 Dec;19(12):1818-1822. doi: 10.1111/dom.13029. Epub 2017 Jul 31.
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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.
Martin Haluzik, D.Sc. principal investigator
General University Hospital, Charles University, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exenatide in people with Coronary Artery Disease and Decreased Left Ventricular Function, run by Charles University, Czech Republic at 1 site in Czechia.
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 5 inclusion and 11 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 2 Feb 2016. 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 Czechia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiac function - echocardiographic parameters (time frame: 90 days after administration of exenatide). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373216, which also lists 1 linked publication.
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 2 Feb 2016.