Glucagon-like Peptide 1 Agonist Exenatide for Improved Glucose Control and Cardiac Function in Patients With Aortocoronary Bypass

Phase 3

Completed

• Conditions: Coronary Artery Disease; Decreased Left Ventricular Function
• Interventions: Drug: Exenatide

• Registration Number: NCT01373216
• Lead Sponsor: Charles University, Czech Republic

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-31
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 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)

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
• diabetic ketoacidosis
• 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
• pregnancy and lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide	Exenatide	Patients with decreased left ventricular function undergoing elective coronary artery by-pass grafting receiving perioperatively i.v. exenatide on top of standard treatment

Primary Outcome Measures

Name	Time	Method
Cardiac function - echocardiographic parameters	90 days after administration of exenatide	* cardiac chamber dimensions; * left ventricular systolic function; * left ventricular diastolic function; * right ventricular systolic function

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse effects	90 days after administration of exenatide

Trial Locations

Locations (1)

General University Hospital; 🇨🇿 Prague, Czech Republic