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)

Anders Jorsal, Henrik Wiggers, Pernille Holmager, Brian Nilsson, Roni Nielsen, Trine Welløv Boesgaard, Anja Kumme, Jacob Eifer Møller, Lars Videbæk, Caroline Kistorp, Ida Gustafsson, Lise Tarnow, Allan Flyvbjerg

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

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.

OriginalsprogEngelsk
TidsskriftBMJ Open
Vol/bind4
Udgave nummer5
Sider (fra-til)e004885
ISSN2044-6055
DOI
StatusUdgivet - 2014

Fingeraftryk

Left Ventricular Function
Type 2 Diabetes Mellitus
Placebos
Echocardiography
Helsinki Declaration
Three-Dimensional Echocardiography
Computer Security
Research Ethics Committees
Diabetes Complications
Hypoglycemic Agents
Liraglutide
Research Personnel
Hormones

Citer dette

Jorsal, Anders ; Wiggers, Henrik ; Holmager, Pernille ; Nilsson, Brian ; Nielsen, Roni ; Boesgaard, Trine Welløv ; Kumme, Anja ; Møller, Jacob Eifer ; Videbæk, Lars ; Kistorp, Caroline ; Gustafsson, Ida ; Tarnow, Lise ; Flyvbjerg, Allan. / 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). I: BMJ Open. 2014 ; Bind 4, Nr. 5. s. e004885.
@article{f922846ecddb43aba9f84f8ae2afba90,
title = "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)",
abstract = "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.",
author = "Anders Jorsal and Henrik Wiggers and Pernille Holmager and Brian Nilsson and Roni Nielsen and Boesgaard, {Trine Well{\o}v} and Anja Kumme and M{\o}ller, {Jacob Eifer} and Lars Videb{\ae}k and Caroline Kistorp and Ida Gustafsson and Lise Tarnow and Allan Flyvbjerg",
note = "Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.",
year = "2014",
doi = "10.1136/bmjopen-2014-004885",
language = "English",
volume = "4",
pages = "e004885",
journal = "B M J Open",
issn = "2044-6055",
publisher = "BMJ Group",
number = "5",

}

Jorsal, A, Wiggers, H, Holmager, P, Nilsson, B, Nielsen, R, Boesgaard, TW, Kumme, A, Møller, JE, Videbæk, L, Kistorp, C, Gustafsson, I, Tarnow, L & Flyvbjerg, A 2014, '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)', BMJ Open, bind 4, nr. 5, s. e004885. https://doi.org/10.1136/bmjopen-2014-004885

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). / Jorsal, Anders; Wiggers, Henrik; Holmager, Pernille; Nilsson, Brian; Nielsen, Roni; Boesgaard, Trine Welløv; Kumme, Anja; Møller, Jacob Eifer; Videbæk, Lars; Kistorp, Caroline; Gustafsson, Ida; Tarnow, Lise; Flyvbjerg, Allan.

I: BMJ Open, Bind 4, Nr. 5, 2014, s. e004885.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - 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)

AU - Jorsal, Anders

AU - Wiggers, Henrik

AU - Holmager, Pernille

AU - Nilsson, Brian

AU - Nielsen, Roni

AU - Boesgaard, Trine Welløv

AU - Kumme, Anja

AU - Møller, Jacob Eifer

AU - Videbæk, Lars

AU - Kistorp, Caroline

AU - Gustafsson, Ida

AU - Tarnow, Lise

AU - Flyvbjerg, Allan

N1 - Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

PY - 2014

Y1 - 2014

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2014-004885

DO - 10.1136/bmjopen-2014-004885

M3 - Journal article

VL - 4

SP - e004885

JO - B M J Open

JF - B M J Open

SN - 2044-6055

IS - 5

ER -