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Effects of Glucagon Like Peptide-1 on Haemodynamic Parameters

C

Chinese PLA General Hospital (301 Hospital)

Status

Unknown

Conditions

Heart Failure

Treatments

Drug: placebo
Drug: liraglutide

Study type

Interventional

Funder types

Other

Identifiers

NCT02490176
S2015-095-01

Details and patient eligibility

About

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.

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 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 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: 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.
Treatment:
Drug: liraglutide
Control group
Placebo Comparator group
Description:
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.
Treatment:
Drug: placebo

Trial contacts and locations

1

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Central trial contact

Wei Ren Chen, M.D.

Data sourced from clinicaltrials.gov

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