Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

Condition(s) targeted: Non-ST-segment Elevation Myocardial Infarction

Intervention: liraglutide (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Chinese PLA General Hospital

Overall contact:
Wei Ren Chen, M.D., Phone: +8610-66939709, Email: chen_weiren@sina.com

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. The investigators planned to evaluate the effects of liraglutide on haemodynamic parameters in patients with non-ST-segment elevation myocardial infarction (NSTEMI).

Official title: Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters in Patients With Non-ST Segment Elevation Myocardial Infarction

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: a change in cardiac output measured by pulse indicator continuous cardiac output (PiCCO) technology

Secondary outcome: a change in left ventricular contractile index measured by PiCCO technology

Detailed description: Non-ST-segment elevation myocardial infarction (NSTEMI) is associated with an increased risk of cardiac death and an efficacious drug with few side effects is necessary. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose. GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. Continuous infusion of GLP-1 (1. 5 pmol/kg/min) has been shown to improve functional recovery after acute myocardial infarction complicated by decreased left ventricular function. Liraglutide, a GLP-1 analogue, was reported to reduce cardiac rupture and infarct size and improve haemodynamic parameters in normal and diabetic mice. Pulse contour analysis can be used to provide haemodynamic measurements. Currently, several pulse contour methods are available, but thermodilution is currently the most widely applied technique. Pulse indicator continuous cardiac output (PiCCO) technology is a combination of transpulmonary thermodilution and pulse contour analysis, which measures haemodynamic variables in a fast and feasible way. Therefore, the aim of this study was to evaluate the effects of liraglutide on haemodynamic variables in patients with NSTEMI using the PiCCO system.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Patients with non-ST-segment elevation myocardial infarction were eligible for the study. Exclusion Criteria: Patients were also excluded for the following reasons: unconscious at presentation; had ST-segment elevation acute myocardial infarction, NSTEMI requiring emergency percutaneous coronary angiography, valvular heart disease, cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; had a history of myocardial infarction, stent implantation, atrial fibrillation, or renal insufficiency; or had previously undergone coronary artery bypass surgery.

Wei Ren Chen, M.D., Phone: +8610-66939709, Email: chen_weiren@sina.com

PLA General Hospital, Beijing, Beijing 100853, China; Recruiting
Wei Ren Chen, M.D., Phone: +8610-66939709, Email: chen_weiren@sina.com
Yun Dai Chen, M.D., Principal Investigator

Related publications:

Liu Y, Zhang L, Liu YF, Yan FF, Zhao YX. Effects of Bulbus allii macrostemi on clinical outcomes and oxidized low-density lipoprotein and plasminogen in unstable angina/non-ST-segment elevation myocardial infarction patients. Phytother Res. 2008 Nov;22(11):1539-43. doi: 10.1002/ptr.2534.

Jeong HC, Ahn YK, Jeong MH, Chae SC, Kim JH, Seong IW, Kim YJ, Hur SH, Choi DH, Hong TJ, Yoon JH, Rhew JY, Chae JK, Kim DI, Chae IH, Koo BK, Kim BO, Lee NH, Hwang JY, Oh SK, Cho MC, Kim KS, Jeong KT, Lee MY, Kim CJ, Chung WS; Korea Acute Myocardial Infarction Registry Investigators. Intensive pharmacologic treatment in patients with acute non ST-segment elevation myocardial infarction who did not undergo percutaneous coronary intervention. Circ J. 2008 Sep;72(9):1403-9.

Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033.

Lønborg J, Vejlstrup N, Kelbæk H, Bøtker HE, Kim WY, Mathiasen AB, Jørgensen E, Helqvist S, Saunamäki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Køber L, Treiman M, Holst JJ, Engstrøm T. Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction. Eur Heart J. 2012 Jun;33(12):1491-9. doi: 10.1093/eurheartj/ehr309. Epub 2011 Sep 14.

Noyan-Ashraf MH, Momen MA, Ban K, Sadi AM, Zhou YQ, Riazi AM, Baggio LL, Henkelman RM, Husain M, Drucker DJ. GLP-1R agonist liraglutide activates cytoprotective pathways and improves outcomes after experimental myocardial infarction in mice. Diabetes. 2009 Apr;58(4):975-83. doi: 10.2337/db08-1193. Epub 2009 Jan 16.

Nikolaidis LA, Mankad S, Sokos GG, Miske G, Shah A, Elahi D, Shannon RP. Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion. Circulation. 2004 Mar 2;109(8):962-5. Epub 2004 Feb 23.

Proulx F, Lemson J, Choker G, Tibby SM. Hemodynamic monitoring by transpulmonary thermodilution and pulse contour analysis in critically ill children. Pediatr Crit Care Med. 2011 Jul;12(4):459-66. doi: 10.1097/PCC.0b013e3182070959. Review.

Starting date: July 2015
Last updated: July 2, 2015