A protocol for a randomised, double-blind, placebo-controlled study of the effect of LIraglutide on left VEntricular function in chronic heart failure patients with and without type 2 diabetes (The LIVE Study).
BACKGROUND
Heart failure is one of the most common cardiovascular complications of diabetes and the most disabling and deadly complication too. Many antidiabetic agents have been associated with increased morbidity and mortality in a subset of patients with chronic heart failure (CHF); thus, new treatment modalities are warranted. Interestingly, a beneficial effect of the incretin hormone, GLP-1, on cardiac function has been suggested in patients with diabetes and patients without diabetes. Liraglutide (Victoza) is a GLP-1 analogue developed for the treatment of type 2 diabetes (T2D); however, its impact on cardiac function has not previously been investigated in patients with CHF. This prompted us to investigate whether liraglutide treatment for 24 weeks improves left ventricular ejection fraction (LVEF) in patients with CHF with and without T2D compared with placebo treatment.


METHODS
An investigator-initiated, multicentre, randomised, double-blind, parallel, placebo-controlled intervention trial. In total, 240 patients with CHF (with and without T2D) with LVEF≤45% will be randomised to either subcutaneous injection of liraglutide 1.8 mg or matching placebo once daily for 24 weeks. The effect of liraglutide on left ventricular function will be evaluated by advanced echocardiography, including three-dimensional contrast echocardiography.


BACKGROUND
The study will be performed and monitored according to the Good Clinical Practice-International Conference on Harmonisation (GCP-ICH) regulations and conducted according to the principles of the Helsinki Declaration. The Danish Medicines Agency, the local Research Ethics Committee and the Danish Data Protection Agency have approved the study.


BACKGROUND
ClinicalTrials.gov Identifier: NCT01472640.
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
Anders
A
Jorsal
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
Henrik
H
Wiggers
Department of Endocrinology and Internal Medicine, Herlev University Hospital, Copenhagen, Denmark.
Pernille
P
Holmager
Department of Cardiology, Herlev University Hospital, Copenhagen, Denmark.
Brian
B
Nilsson
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
Roni
R
Nielsen
Steno Diabetes Center, Gentofte, Denmark.
Trine Welløv
TW
Boesgaard
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Anja
A
Kumme
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Jacob Eifer
JE
Møller
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Lars
L
Videbæk
Department of Endocrinology and Internal Medicine, Herlev University Hospital, Copenhagen, Denmark.
Caroline
C
Kistorp
Department of Cardiology, Hvidovre University Hospital, Copenhagen, Denmark.
Ida
I
Gustafsson
Steno Diabetes Center, Gentofte, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark Nordsjaellands University Hospital, Hilleroed, Denmark.
Lise
L
Tarnow
Faculty of Health, Aarhus University, Aarhus, Denmark Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.
Allan
A
Flyvbjerg
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology*; D004311:Double-Blind Method; D006333:Heart Failure / Q000150:complications / Q000503:physiopathology*; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000069450:Liraglutide / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D012107:Research Design; D016277:Ventricular Function, Left / Q000187:drug effects*
D007004:Hypoglycemic Agents; D000069450:Liraglutide