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Completed

NCT Number: NCT01373216

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Decreased Left Ventricular Function Heart Diseases Myocardial Ischemia Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General University Hospital

Prague, 128 08, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of participants with adverse effects

    Time frame: 90 days after administration of exenatide

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

EXEnatide in Patients Undergoing Coronary Artery Bypass Grafting for Improved glUcose conTrol and hemodynamIc ValuEs

Acronym: Executive

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 14, 2011
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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