The aim of this trial is to assess the effect of Empagliflozin on lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed. The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.
The Empire Prevent: Metabolic is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Cardiac. The Empire Prevent: Metabolic is designed to enroll at least 120 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
165
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
Ventricular epicardial adipose tissue (EAT) mass
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Time frame: 180 days
Estimated extracellular volume (eECV)
Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)
Time frame: 180 days
Total pericardial adipose tissue volume
Between-group difference in the change of pericardial adipose tissue volume assessed by cardiac MRI
Time frame: 180 days
Total epicardial adipose tissue (EAT) volume
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Time frame: 180 days
Plasma volume
Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin
Time frame: 180 days
Right ventricular end-diastolic volume index, RVEDVI
Between-group difference in the change of RVEDVI assessed by cardiac MRI
Time frame: 180 days
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