The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure

Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Cardiac): A Randomized Controlled Trial

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

Inclusion Criteria:

• Body mass index >28kg/m2
• Age 60-84 years
• Established risk factor for developing heart failure, defined as at least one of the following:
• hypertension
• ischemic heart disease
• stroke/transient cerebral ischemia
• chronic kidney disease (eGFR 30-45ml/min/1.73m2)

Exclusion Criteria:

• Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
• Heart failure with reduced ejection fraction (LVEF <40%)
• Inability to perform exercise test
• Dementia
• Severe non-compliance
• Substance abuse
• Severe chronic obstructive pulmonary disease (FEV1<50% expected value)
• Permanent atrial fibrillation
• GFR <30 ml/min/1,73m2
• Severe peripheral artery disease
• Cancer treatment within one year beside prostate cancer and basal cell carcinoma
• Severe aortic or mitral valve disease
• Pregnancy or breastfeeding
• Acute hospital admission within 30 days
• Participation in other pharmacological study