The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.
The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
191
Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
Placebo matches the active drug in appearance, odor and labelling
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark
Left ventricular mass index
Between-group difference in the change of left ventricular mass index (LVMI) assessed by cardiac magnetic resonance image
Time frame: 180 days
Maximal oxygen consumption
Between-group difference in the change of maximal oxygen consumption (peak VO2) assessed by cardiopulmonary exercise test
Time frame: 180 days
Left ventricular volume
Between-group difference in the change of left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI) assessed by cardiac magnetic resonance image
Time frame: 180 days
Left ventricular function
Between-group difference in the change of first phase ejection fraction and left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance image
Time frame: 180 days
Daily activity level
Between-group difference in the change of daily activity level assessed by accelerometer
Time frame: 180 days
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