Clinical trial NCT02930265: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Cardiomyopathy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: main adverse cardiovascular events
timeFrame: Followed up for 6 months after enrolled in the study
Secondary outcomes:
measure: New York Heart Association functional class
timeFrame: Followed up for 6 months after enrolled in the study
measure: left ventricular ejection fraction
timeFrame: Followed up for 6 months after enrolled in the study
measure: 6-minute walk test
timeFrame: Followed up for 6 months after enrolled in the study
measure: KCCQ (Kansas City cardiomyopathy questionnaire) clinical total score
timeFrame: Followed up for 6 months after enrolled in the study
Other outcomes:
Locations:
city: Peking
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
Study officials:
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