Effects of GLP-1 on Chronic Heart Failure

January 7, 2016 updated by: Shi Yang

Effects of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With Type 2 Diabetes

The investigators planned to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 acute myocardial infarction. However, the effects of GLP-1 on chronic heart failure patients with type 2 diabetes remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Study Type

Interventional

Enrollment (Anticipated)

68

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
      • Beijing, Beijing, China, 100853
        • Recruiting
        • PLA 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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic heart failure patients with type 2 diabetes (NYHA-class I, II or III) were eligible for the study

Exclusion Criteria:

  • CHF (NYHA class IV)
  • Type 1 diabetes
  • Hospitalisation due to incompensated heart disease within 30 days prior to randomisation
  • Myocardial infarction within the past 3 months before screening
  • Coronary revascularisation within the past 3 months before screening
  • Atrial fibrillation with ventricular frequency >100/min in rest
  • ECG suggestive of malignant ventricular arrhythmia
  • Prolonged QT-interval (>500 ms)
  • Valvular heart disease
  • Current myocardial or pericardial infection
  • Obstructive hypertrophic cardiomyopathy
  • Cancer unless in complete remission for ≥5 years
  • Acute pancreatitis
  • Compromised kidney function (eGFR <30 mL/min), dialysis or kidney transplantation
  • History of thyroidea adenoma or carcinoma

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLP-1 group
drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg liraglutide once daily for 1 week, then 1.2 mg liraglutide for another 1 week, and then 1.8 mg liraglutide to the end.
Drug: GLP-1
Liraglutide were taken daily for 3 months
Other Names:
  • Liraglutide
Placebo Comparator: Control group
drug: placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg placebo once daily for 1 week, then 1.2 mg placebo for another 1 week, and then 1.8 mg placebo to the end.
Drug: Placebo
Placebo were taken daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
left ventricular ejection fraction measured by 3D echocardiography
Time Frame: 3 months
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plasma NT-proBNP levels
Time Frame: 3 months
a change in plasma NT-proBNP levels at 3 months after treatment
3 months
a change in 6-minute walk distance
Time Frame: 3 months
The change in 6-minute walk distance at 3 months after treatment.
3 months
differences in the incidences of treatment-emergent adverse events
Time Frame: 3 months
differences in the incidences of treatment-emergent adverse events at 3 months
3 months

Collaborators and Investigators

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

Sponsor

Shi Yang

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

January 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301nlxnk

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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