Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

Study Overview
=================
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.

Official Title
-----------------
Effects of Liraglutide on Hemodynamic Parameters in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: 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. | Drug: liraglutide<br>* Liraglutide were taken daily for 7 days<br>|
| Placebo Comparator: Control group<br>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. | Drug: placebo<br>* Placebo were taken daily for 7 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a change in left ventricular contractile index measured by PiCCO technology | The change in left ventricular contractile index was measured at 7 days after treatment. | 7 days after treatment |