The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus

Sponsor
Flyvbjerg, Allan, DMSc
Study ID
NCT01472640
Status
Completed

Conditions

  • Chronic Heart Failure
  • Hyperglycemia

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    1.8 mg sc QOD
  • placebo — DRUG
    1 U sc QOD

Study Details

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.

Key Dates

Start date
Nov 30, 2011
Status verified
Oct 2015
Primary completion
Sep 30, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
240 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutid
    Liraglutid
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Change in Left ventricular function from visit 1 to week 24, measured by Ecco [ Time Frame: 24 weeks ]

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