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

October 8, 2016 updated by: Qian geng, Chinese PLA General Hospital

Chinese People's Liberation Army General Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100853
        • Chinese People's Liberation Army General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liraglutide intervention group
Liraglutide intervention group will accept ischemic cardiomyopathy conventional drugs and Liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)
Drug: Liraglutide
Liraglutide intervention group will accept liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)
Other Names:
  • Saxenda
No Intervention: Control group
Control group will accept ischemic cardiomyopathy conventional drugs and a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
main adverse cardiovascular events
Time Frame: Followed up for 6 months after enrolled in the study
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
Followed up for 6 months after enrolled in the study

Secondary Outcome Measures

Outcome Measure
Time Frame
New York Heart Association functional class
Time Frame: Followed up for 6 months after enrolled in the study
Followed up for 6 months after enrolled in the study
left ventricular ejection fraction
Time Frame: Followed up for 6 months after enrolled in the study
Followed up for 6 months after enrolled in the study
6-minute walk test
Time Frame: Followed up for 6 months after enrolled in the study
Followed up for 6 months after enrolled in the study
KCCQ (Kansas City cardiomyopathy questionnaire) clinical total score
Time Frame: Followed up for 6 months after enrolled in the study
Followed up for 6 months after enrolled in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 8, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

October 8, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qs20160920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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