search
Back to results

Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLP-1 group

Control group

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 2, 2015
Last Updated
February 26, 2016
Sponsor
Chinese PLA General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02490176
Brief Title
Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters
Official Title
Effects of Liraglutide on Hemodynamic Parameters in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLP-1 group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Description
Liraglutide were taken daily for 7 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo were taken daily for 7 days
Primary Outcome Measure Information:
Title
a change in cardiac output measured by pulse indicator continuous cardiac output (PiCCO) technology
Description
The primary efficacy endpoint was the effect of liraglutide on cardiac output (CO) at 7 days compared with placebo.
Time Frame
7 days after treatment
Secondary Outcome Measure Information:
Title
a change in left ventricular contractile index measured by PiCCO technology
Description
The change in left ventricular contractile index was measured at 7 days after treatment.
Time Frame
7 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Ren Chen, M.D.
Phone
+8610-66939709
Email
chen_weiren@sina.com
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Ren Chen, M.D.
Phone
+8610-66939709
Email
chen_weiren@sina.com
First Name & Middle Initial & Last Name & Degree
Yun Dai Chen, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
18688814
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.
Results Reference
background
PubMed Identifier
18724013
Citation
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.
Results Reference
background
PubMed Identifier
19195607
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.
Results Reference
background
PubMed Identifier
21920963
Citation
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.
Results Reference
background
PubMed Identifier
19151200
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.
Results Reference
background
PubMed Identifier
14981009
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. doi: 10.1161/01.CIR.0000120505.91348.58. Epub 2004 Feb 23.
Results Reference
background
PubMed Identifier
21263372
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.
Results Reference
background

Learn more about this trial

Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

We'll reach out to this number within 24 hrs