Assessment of glycemic compensation and hemodynamic parameteres in patients after administration of GLP-1 agonist exenatid during and after the implantation of aortocoronary by-pass.

EXEnatide in patients undergoing Coronary artery bypass grafting for improved glUcose conTrol and hemodynamIc ValuEs - EXECUTIVE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023839-42-CZ

Enrollment

Registered

2011-01-26

Start date

2011-04-29

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Patients with elective coronary artery bypass grafting with LV systolic dysfunction (EF LV = 50%) MedDRA version: 14.1 Level: PT Classification code 10011077 Term: Coronary artery bypass System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 10014698 - Endocrine disorders

Interventions

Trade Name: Byetta Pharmaceutical Form: Solution for injection INN or Proposed INN: EXENATIDE CAS Number: 141758-74-9 Concentration unit: µg microgram(s) Concentration type: equal Concentration number

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - elective coronary artery bypass grafting operation (CABG) and/or valvuloplasty - LV systolic dysfunction (EF LV = 50%) - Age 18 - 85 years - 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18

Exclusion criteria

Exclusion criteria: - allergy to exenatide - allergy to insulin - mental incapacity or language barrier - use of incretin-based therapies <3 months before inclusion in the study - established autonomic neuropathy - 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 - diabetic ketoacidosis - pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhytmic and inotropic treatment and glucose control after CABG operation.;Secondary Objective: To examine safety and tolerability of peri-operative administration of exenatide in type 2 diabetic patients undergoing coronary artery bypass grafting operation (CABG).;Primary end point(s): A: Echocardiographic parameters: - cardiac chamber dimensions (including left ventricle, left atrium, right atrium and right ventricle) - left ventricular systolic function - ejection fraction of left ventricular (%) with the use of the Simpson’s method on standard 2-dimensional images, RWMA (regional wall motion abnormalities) according to 4 degrees system and WMSI (wall motion score index) with the use of the 16-segment model of the American Society of Echocardiography, VTI (measured in left ventricular outflow tract) - left ventricular diastolic function - transmitral inflow early filling peak velocity (E), atrial peak velocity (A), E/A ratio and deceleration time (DTE), pulmonary vein flow (or hepatic vein flow), Doppler tissue imaging of mitral annular motion (E/e‘) - right ventricular systolic function - with the use of TAPSE (tricuspid anulus plane systolic excursion) B. perioperative hemodynamics (messured by Swan-Ganz catheter) Postoperatively every 3 (for first 24 hours) and 6 hours (for another 24-48 h) - cardiac output and index - stroke volume - mean arterial pressure - pulmonary artery pressures) - heart rate C: Antiarrhytmic treatment - need for antiarhytmic Tx – No of patients and total dose of amiodarone - need for temporary pacing D: Dose of inotropic drugs - total dose of inotropes for each patient and total time (in hours) of infusion (preferable dobutamine or milrinone if necessary) - total dose of vasopressors and total time of infusion (norepinephrine) (indication for inotropes (dobutamin f	—

Measure

Time frame

Main Objective: To examine whether pre- and peri-operative administration of exenatide affects perioperative hemodynamics, echocardiographic parameters, necessity of antiarrhytmic and inotropic treatment and glucose control after CABG operation.;Secondary Objective: To examine safety and tolerability of peri-operative administration of exenatide in type 2 diabetic patients undergoing coronary artery bypass grafting operation (CABG).;Primary end point(s): A: Echocardiographic parameters: - cardiac chamber dimensions (including left ventricle, left atrium, right atrium and right ventricle) - left ventricular systolic function - ejection fraction of left ventricular (%) with the use of the Simpson’s method on standard 2-dimensional images, RWMA (regional wall motion abnormalities) according to 4 degrees system and WMSI (wall motion score index) with the use of the 16-segment model of the American Society of Echocardiography, VTI (measured in left ventricular outflow tract) - left ventricular diastolic function - transmitral inflow early filling peak velocity (E), atrial peak velocity (A), E/A ratio and deceleration time (DTE), pulmonary vein flow (or hepatic vein flow), Doppler tissue imaging of mitral annular motion (E/e‘) - right ventricular systolic function - with the use of TAPSE (tricuspid anulus plane systolic excursion) B. perioperative hemodynamics (messured by Swan-Ganz catheter) Postoperatively every 3 (for first 24 hours) and 6 hours (for another 24-48 h) - cardiac output and index - stroke volume - mean arterial pressure - pulmonary artery pressures) - heart rate C: Antiarrhytmic treatment - need for antiarhytmic Tx – No of patients and total dose of amiodarone - need for temporary pacing D: Dose of inotropic drugs - total dose of inotropes for each patient and total time (in hours) of infusion (preferable dobutamine or milrinone if necessary) - total dose of vasopressors and total time of infusion (norepinephrine) (indication for inotropes (dobutamin f

—

Secondary

Measure	Time frame
Secondary end point(s): - tolerability of exenatide - safety (side effects) - troponin I levels first postoperative day, - trends, medians or means of lactate, SvO2 (PAC), number of ischaemic events (according to ECG ST analysis), - exploratory endpoints (biomarkers of inflammation (e.g. CRP), adipokines etc.);Timepoint(s) of evaluation of this end point: 90 days after the beginning of exenatid administration	—

Measure

Time frame

Secondary end point(s): - tolerability of exenatide - safety (side effects) - troponin I levels first postoperative day, - trends, medians or means of lactate, SvO2 (PAC), number of ischaemic events (according to ECG ST analysis), - exploratory endpoints (biomarkers of inflammation (e.g. CRP), adipokines etc.);Timepoint(s) of evaluation of this end point: 90 days after the beginning of exenatid administration

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Countries

Czech Republic

Contacts

Public Contact3rd Department of Medicine

General University Hospital and Charles University in Prague

milos_mraz@yahoo.co.uk+420224 96 66 94

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026