Effects of GLP-1 on Chronic Heart Failure

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

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: GLP-1
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1 group<br>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<br>* Liraglutide were taken daily for 3 months<br>* Other names: Liraglutide;|
| Placebo Comparator: Control group<br>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<br>* Placebo were taken daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction measured by 3D echocardiography | 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 | a change in plasma NT-proBNP levels at 3 months after treatment | 3 months | 
| a change in 6-minute walk distance | The change in 6-minute walk distance at 3 months after treatment. | 3 months | 
| differences in the incidences of treatment-emergent adverse events | differences in the incidences of treatment-emergent adverse events at 3 months | 3 months |