Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

NCT02490176 | Unknown DMC

• 1 other identifier: S2015-095-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• a change in left ventricular contractile index measured by PiCCO technology

  7 days after treatment

Study Arms (2)

GLP-1 group

EXPERIMENTAL

drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 7 days. After admission, the patients were treated with 0.6 mg liraglutide once daily for 2 day, then 1.2 mg liraglutide for another 2 day, and then 1.8 mg liraglutide for 3 days.

Drug: liraglutide

Control group

PLACEBO COMPARATOR

drug: placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: 7 days. After admission, the patients were treated with 0.6 mg placebo once daily for 2 day, then 1.2 mg placebo for another 2 day, and then 1.8 mg placebo for 3 days.

Drug: placebo

Interventions

liraglutide DRUG

Liraglutide were taken daily for 7 days

GLP-1 group

placebo DRUG

Placebo were taken daily for 7 days

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 18688814 BACKGROUND

• 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. doi: 10.1253/circj.cj-08-0048.

  PMID: 18724013 BACKGROUND

• 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.

  PMID: 19195607 BACKGROUND

• Lonborg J, Vejlstrup N, Kelbaek H, Botker HE, Kim WY, Mathiasen AB, Jorgensen E, Helqvist S, Saunamaki K, Clemmensen P, Holmvang L, Thuesen L, Krusell LR, Jensen JS, Kober L, Treiman M, Holst JJ, Engstrom 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.

  PMID: 21920963 BACKGROUND

• 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.

  PMID: 19151200 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000120505.91348.58. Epub 2004 Feb 23.

  PMID: 14981009 BACKGROUND

• 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.

  PMID: 21263372 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Wei Ren Chen, M.D.

CONTACT

+8610-66939709; chen_weiren@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 3, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

CN (1)