search
Back to results

Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy

Primary Purpose

Ischemic Cardiomyopathy

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

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients With Ischemic Cardiomyopathy: The clinical manifestations of heart failure (NYHA class II-IV grade), evidence of cardiac dysfunction (LVEF ≤40%, and LVEDD ≥55mm) and previous coronary angiography showed one or more severe coronary artery stenosis.

Exclusion Criteria:

  • Valvular heart disease
  • dilated cardiomyopathy
  • patients requiring emergency PCI
  • patients with cardiogenic shock;
  • there have been recent acute myocardial infarction in one month;
  • there have been recent acute stroke in one month;
  • estimated glomerular filtration over rate eGFR <30ml / min / 1.73m2 (according to MDRD formula);
  • malignant tumor
  • severe liver failure
  • respiratory failure

Sites / Locations

  • Chinese People's Liberation Army General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Liraglutide intervention group

Control group

Arm Description

Liraglutide intervention group will accept ischemic cardiomyopathy conventional drugs and Liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)

Control group will accept ischemic cardiomyopathy conventional drugs and a placebo

Outcomes

Primary Outcome Measures

main adverse cardiovascular events
Primary end point of the study is main adverse cardiovascular events including Recurrent myocardial infarction, recurrent angina, revascularization, all-cause death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure again

Secondary Outcome Measures

New York Heart Association functional class
left ventricular ejection fraction
6-minute walk test
KCCQ (Kansas City cardiomyopathy questionnaire) clinical total score

Full Information

First Posted
September 23, 2016
Last Updated
October 8, 2016
Sponsor
Chinese PLA General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02930265
Brief Title
Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy
Official Title
Chinese People's Liberation Army General Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
March 2018 (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
It has been known that liraglutide reduces infarct size, improved left ventricular function, reduce myocardial stunning, and play a protective role in myocardial ischemia-reperfusion injury for patients with acute myocardial infarction. But it is not sure whether liraglutide can benefit patients with ischemic cardiomyopathy. This study aim to explore the effect of Liraglutide in improving cardiac function for patients with ischemic cardiomyopathy.
Detailed Description
Investigators will enroll 400 patients with ischemic cardiomyopathy who were admitted to the Chinese PLA General Hospital. All patients enrolled in this study will collect detailed baseline clinical data, including blood, enzymes (troponin, creatine kinase), blood sugar, serum creatinine, blood lipid levels (LDL lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, total cholesterol), brain natriuretic peptide (BNP), inflammatory markers (high sensitivity C- reactive protein, interleukin-6), endothelin (ET-1), pancreas glucagon-like peptide -1 (GLP-1) and superoxide dismutase (SOD). The investigators randomly assign eligible patients in a 1:1 ratio to either liraglutide intervention group (N = 200) or control group (N = 200), liraglutide intervention group will accept ischemic cardiomyopathy conventional drugs and liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day), Control group will accept ischemic cardiomyopathy conventional drugs and a placebo. Primary end point of the study is main adverse cardiovascular events including Recurrent myocardial infarction, recurrent angina, revascularization, all-cause death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure again. Secondary end point of the study was 1) New York Heart Association functional class, 2) left ventricular ejection fraction, 3) 6-minute walk test, 4) KCCQ clinical total score, 5) changes in blood glucose levels during follow-up, blood lipid levels and body weight

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Liraglutide intervention group
Arm Type
Active Comparator
Arm Description
Liraglutide intervention group will accept ischemic cardiomyopathy conventional drugs and Liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will accept ischemic cardiomyopathy conventional drugs and a placebo
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Saxenda
Intervention Description
Liraglutide intervention group will accept liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)
Primary Outcome Measure Information:
Title
main adverse cardiovascular events
Description
Primary end point of the study is main adverse cardiovascular events including Recurrent myocardial infarction, recurrent angina, revascularization, all-cause death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure again
Time Frame
Followed up for 6 months after enrolled in the study
Secondary Outcome Measure Information:
Title
New York Heart Association functional class
Time Frame
Followed up for 6 months after enrolled in the study
Title
left ventricular ejection fraction
Time Frame
Followed up for 6 months after enrolled in the study
Title
6-minute walk test
Time Frame
Followed up for 6 months after enrolled in the study
Title
KCCQ (Kansas City cardiomyopathy questionnaire) clinical total score
Time Frame
Followed up for 6 months after enrolled in the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients With Ischemic Cardiomyopathy: The clinical manifestations of heart failure (NYHA class II-IV grade), evidence of cardiac dysfunction (LVEF ≤40%, and LVEDD ≥55mm) and previous coronary angiography showed one or more severe coronary artery stenosis. Exclusion Criteria: Valvular heart disease dilated cardiomyopathy patients requiring emergency PCI patients with cardiogenic shock; there have been recent acute myocardial infarction in one month; there have been recent acute stroke in one month; estimated glomerular filtration over rate eGFR <30ml / min / 1.73m2 (according to MDRD formula); malignant tumor severe liver failure respiratory failure
Facility Information:
Facility Name
Chinese People's Liberation Army General Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19552923
Citation
Matsubara M, Kanemoto S, Leshnower BG, Albone EF, Hinmon R, Plappert T, Gorman JH 3rd, Gorman RC. Single dose GLP-1-Tf ameliorates myocardial ischemia/reperfusion injury. J Surg Res. 2011 Jan;165(1):38-45. doi: 10.1016/j.jss.2009.03.016. Epub 2009 Apr 16.
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
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
27295427
Citation
Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.
Results Reference
background
PubMed Identifier
22544917
Citation
Gejl M, Sondergaard HM, Stecher C, Bibby BM, Moller N, Botker HE, Hansen SB, Gjedde A, Rungby J, Brock B. Exenatide alters myocardial glucose transport and uptake depending on insulin resistance and increases myocardial blood flow in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jul;97(7):E1165-9. doi: 10.1210/jc.2011-3456. Epub 2012 Apr 27.
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
26849684
Citation
Chen WR, Tian F, Chen YD, Wang J, Yang JJ, Wang ZF, Da Wang J, Ning QX. Effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction. Int J Cardiol. 2016 Apr 1;208:109-14. doi: 10.1016/j.ijcard.2015.12.009. Epub 2015 Dec 15.
Results Reference
background
PubMed Identifier
26573925
Citation
Chen WR, Shen XQ, Zhang Y, Chen YD, Hu SY, Qian G, Wang J, Yang JJ, Wang ZF, Tian F. Effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction. Endocrine. 2016 Jun;52(3):516-26. doi: 10.1007/s12020-015-0798-0. Epub 2015 Nov 16.
Results Reference
background
PubMed Identifier
26542491
Citation
Chen WR, Hu SY, Chen YD, Zhang Y, Qian G, Wang J, Yang JJ, Wang ZF, Tian F, Ning QX. Effects of liraglutide on left ventricular function in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Am Heart J. 2015 Nov;170(5):845-54. doi: 10.1016/j.ahj.2015.07.014. Epub 2015 Jul 26.
Results Reference
background
PubMed Identifier
21586690
Citation
Read PA, Hoole SP, White PA, Khan FZ, O'Sullivan M, West NE, Dutka DP. A pilot study to assess whether glucagon-like peptide-1 protects the heart from ischemic dysfunction and attenuates stunning after coronary balloon occlusion in humans. Circ Cardiovasc Interv. 2011 Jun;4(3):266-72. doi: 10.1161/CIRCINTERVENTIONS.110.960476. Epub 2011 May 17.
Results Reference
background
PubMed Identifier
18819705
Citation
Garber A, Henry R, Ratner R, Garcia-Hernandez PA, Rodriguez-Pattzi H, Olvera-Alvarez I, Hale PM, Zdravkovic M, Bode B; LEAD-3 (Mono) Study Group. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet. 2009 Feb 7;373(9662):473-81. doi: 10.1016/S0140-6736(08)61246-5. Epub 2008 Sep 24.
Results Reference
background
PubMed Identifier
18931095
Citation
Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
Results Reference
background
PubMed Identifier
19289857
Citation
Zinman B, Gerich J, Buse JB, Lewin A, Schwartz S, Raskin P, Hale PM, Zdravkovic M, Blonde L; LEAD-4 Study Investigators. Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD). Diabetes Care. 2009 Jul;32(7):1224-30. doi: 10.2337/dc08-2124. Epub 2009 Mar 16. Erratum In: Diabetes Care. 2010 Mar;33(3):692.
Results Reference
background
PubMed Identifier
23835684
Citation
Kim SH, Abbasi F, Lamendola C, Liu A, Ariel D, Schaaf P, Grove K, Tomasso V, Ochoa H, Liu YV, Chen YD, Reaven G. Benefits of liraglutide treatment in overweight and obese older individuals with prediabetes. Diabetes Care. 2013 Oct;36(10):3276-82. doi: 10.2337/dc13-0354. Epub 2013 Jul 8.
Results Reference
background
PubMed Identifier
27038735
Citation
Zhang Y, Zhou H, Wu W, Shi C, Hu S, Yin T, Ma Q, Han T, Zhang Y, Tian F, Chen Y. Liraglutide protects cardiac microvascular endothelial cells against hypoxia/reoxygenation injury through the suppression of the SR-Ca(2+)-XO-ROS axis via activation of the GLP-1R/PI3K/Akt/survivin pathways. Free Radic Biol Med. 2016 Jun;95:278-92. doi: 10.1016/j.freeradbiomed.2016.03.035. Epub 2016 Mar 31.
Results Reference
background

Learn more about this trial

Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy

We'll reach out to this number within 24 hrs