Henrik Wiggers

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)

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  • Anders Jorsal
  • Henrik Wiggers
  • Pernille Holmager, Department of Endocrinology and Internal Medicine, Herlev University Hospital, Copenhagen, Denmark.
  • ,
  • Brian Nilsson, Institut for Klinisk Medicin, Denmark
  • Roni Nielsen, Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
  • ,
  • Trine Welløv Boesgaard, Steno Diabetes Center, Gentofte, Denmark., Denmark
  • Anja Kumme, Department of Cardiology, Odense University Hospital, Odense, Denmark., Denmark
  • Jacob Eifer Møller, Department of Cardiology, Odense University Hospital, Odense, Denmark., Denmark
  • Lars Videbæk, Department of Cardiology, Odense University Hospital, Odense, Denmark.
  • ,
  • Caroline Kistorp, Department of Endocrinology and Internal Medicine, Herlev University Hospital, Copenhagen, Denmark.
  • ,
  • Ida Gustafsson, Department of Cardiology, Hvidovre University Hospital, Copenhagen, Denmark., Denmark
  • Lise Tarnow, Steno Diabetes Center, Gentofte, Denmark Faculty of Health, Aarhus University, Aarhus, Denmark Nordsjaellands University Hospital, Hilleroed, Denmark., Denmark
  • Allan Flyvbjerg, Faculty of Health, Aarhus University, Aarhus, Denmark Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark., Denmark

INTRODUCTION: 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 AND ANALYSIS: 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.

ETHICS AND DISSEMINATION: 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.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT01472640.

Original languageEnglish
JournalBMJ Open
Volume4
Issue5
Pages (from-to)e004885
ISSN2044-6055
DOIs
Publication statusPublished - 2014

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