The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus
Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control in patients with the combination of T2D and CHF is complicated and the currently available treatments have proven to be inadequate in clinical trials.
Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular ejection fraction (LVEF) in CHF patients with and without T2D.
Multicenter, randomized, double blind study of 240 patients with documented systolic CHF (50% with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic and diastolic function will be evaluated by advanced echocardiography
Primary outcome parameter is change in LVEF from visit 1 to week 24.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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)|
- Change in Left ventricular function from visit 1 to week 24, measured by Ecco [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Primary objective: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular function in Chronic heart faillure patients with and without type 2 diabetes after 24 weeks of treatment.
- left ventricular diastolic function [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]Secondary objectives: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular diastolic function, on plasma levels of NT-proBNP, on symptoms of heart failure and quality of life over 24 weeks of treatment.
|Study Start Date:||November 2011|
|Study Completion Date:||October 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Liraglutid
1.8 mg sc QOD
Other Name: Victoza
Placebo Comparator: Placebo
1 U sc QOD
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472640
|Skejby University Hospital|
|Aarhus, Denmark, 8200|
|Steno Diabetes Center|
|Gentofte, Denmark, 2820|
|Herlev University Hospital|
|Herlev, Denmark, 2730|
|Odense University Hospital|
|Odense, Denmark, 5000|
|Study Chair:||Allan Flyvbjerg, dean||University of Aarhus|