Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

Heart Failure Clinical Trial

Official title:

Effects of Liraglutide on Hemodynamic Parameters in Patients With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02490176
• Other study ID #: S2015-095-01
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2015
• Last updated: February 26, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Chinese PLA General Hospital
• Contact: Wei Ren Chen, M.D.
• Phone: +8610-66939709
• Email: chen_weiren[@]sina.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

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 heart failure.

Description:

Heart failure (HF) is a major cause of morbidity and mortality world wide. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system. In our previous study, the GLP-1 analogue liraglutide could improve left ventricular function in patients with non-ST-segment elevation myocardial infarction. However, the effects of GLP-1 on HF patients remain unclear. Pulse indicator continuous cardiac output (PiCCO) technology is a combination of transpulmonary thermodilution and pulse contour analysis, which measures hemodynamic variables (left ventricular ejection fraction, volumes, and mass) in a fast and feasible way. Therefore, the aim of this study was to evaluate the effects of liraglutide on hemodynamic variables in HF patients using the PiCCO system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients with HF were eligible for the study. Diagnosis of HF was based on an impaired ejection fraction (<50%).

Exclusion Criteria:

Patients were also excluded for the following reasons: unconscious at presentation; valvular heart disease, cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; or renal insufficiency.

Study Design

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• liraglutide
Liraglutide were taken daily for 7 days
• placebo
Placebo were taken daily for 7 days

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a change in cardiac output measured by pulse indicator continuous cardiac output (PiCCO) technology	The primary efficacy endpoint was the effect of liraglutide on cardiac output (CO) at 7 days compared with placebo.	7 days after treatment	No
Secondary	a change in left ventricular contractile index measured by PiCCO technology	The change in left ventricular contractile index was measured at 7 days after treatment.	7 days after treatment	No