Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

Not Applicable

• Conditions: Heart Failure
• Interventions: Drug: placebo; Drug: liraglutide

• Registration Number: NCT02490176
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and GLP-1 analogues were recently introduced for the treatment of acute myocardial infarction. The investigators planned to evaluate the effects of liraglutide on haemodynamic parameters in patients with heart failure.

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 non-ST-segment elevation myocardial infarction. However, the effects of GLP-1 on HF patients remain unclear. Pulse indicator continuous cardiac output (PiCCO) technology is a combination of transpulmonary thermodilution and pulse contour analysis, which measures hemodynamic variables (left ventricular ejection fraction, volumes, and mass) in a fast and feasible way. Therefore, the aim of this study was to evaluate the effects of liraglutide on hemodynamic variables in HF patients using the PiCCO system.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-02
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with HF were eligible for the study. Diagnosis of HF was based on an impaired ejection fraction (<50%).

Exclusion Criteria

Patients were also excluded for the following reasons: unconscious at presentation; valvular heart disease, cardiogenic shock, hypoglycaemia, or diabetic ketoacidosis; or renal insufficiency.

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: 7 days. After admission, the patients were treated with 0.6 mg placebo once daily for 2 day, then 1.2 mg placebo for another 2 day, and then 1.8 mg placebo for 3 days.
GLP-1 group	liraglutide	drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 7 days. After admission, the patients were treated with 0.6 mg liraglutide once daily for 2 day, then 1.2 mg liraglutide for another 2 day, and then 1.8 mg liraglutide for 3 days.

Primary Outcome Measures

Name	Time	Method
a change in cardiac output measured by pulse indicator continuous cardiac output (PiCCO) technology	7 days after treatment	The primary efficacy endpoint was the effect of liraglutide on cardiac output (CO) at 7 days compared with placebo.

Secondary Outcome Measures

Name	Time	Method
a change in left ventricular contractile index measured by PiCCO technology	7 days after treatment	The change in left ventricular contractile index was measured at 7 days after treatment.

Trial Locations

Locations (1)

PLA General Hospital; 🇨🇳 Beijing, Beijing, China