Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

NCT ID: NCT02490176

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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GLP-1 group

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.

Group Type EXPERIMENTAL

liraglutide

Intervention Type DRUG

Liraglutide were taken daily for 7 days

Control group

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo were taken daily for 7 days

Interventions

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liraglutide

Liraglutide were taken daily for 7 days

Intervention Type DRUG

placebo

Placebo were taken daily for 7 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chen Wei Ren, MD

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Ren Chen, M.D.

Role: CONTACT

Phone: +8610-66939709

Email: [email protected]

Facility Contacts

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Wei Ren Chen, M.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 18688814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18724013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19195607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21920963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19151200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14981009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21263372 (View on PubMed)

Other Identifiers

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S2015-095-01

Identifier Type: -

Identifier Source: org_study_id