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
About this trial
This is an interventional treatment trial for Ischemic Cardiomyopathy
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
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
NCT ID
NCT02930265
First Posted
September 23, 2016
Last Updated
October 8, 2016
Sponsor
Chinese PLA General Hospital
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
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Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy
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