Effects of GLP-1 on Chronic Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Drug: Placebo; Drug: GLP-1

• Registration Number: NCT02650596
• Lead Sponsor: Shi Yang

Brief Summary

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

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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-08
• Last Update Posted: 2016-01-08
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	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.
GLP-1 group	GLP-1	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.

Primary Outcome Measures

Name	Time	Method
left ventricular ejection fraction measured by 3D echocardiography	3 months	The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months.

Secondary Outcome Measures

Name	Time	Method
a change in 6-minute walk distance	3 months	The change in 6-minute walk distance at 3 months after treatment.
plasma NT-proBNP levels	3 months	a change in plasma NT-proBNP levels at 3 months after treatment
differences in the incidences of treatment-emergent adverse events	3 months	differences in the incidences of treatment-emergent adverse events at 3 months

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China