The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT01472640|
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : October 12, 2015
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.
|Condition or disease||Intervention/treatment|
|Hyperglycemia Chronic Heart Failure||Drug: liraglutide Drug: placebo|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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)|
|Study Start Date :||November 2011|
|Primary Completion Date :||September 2015|
|Study Completion Date :||October 2015|
Active Comparator: Liraglutid
1.8 mg sc QOD
Other Name: Victoza
Placebo Comparator: Placebo
1 U sc QOD
- Change in Left ventricular function from visit 1 to week 24, measured by Ecco [ Time Frame: 24 weeks ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|