Effects of GLP-1 on Chronic Heart Failure

Shi Yang

Status: Unknown

Conditions: Heart Failure

Treatments: Drug: GLP-1; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02650596

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Details and patient eligibility

About

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

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

GLP-1 group

Experimental group

Description:

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.

Treatment:

Drug: GLP-1

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo