SGLT2 Inhibition in Hemodialysis

• Status: Not yet recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor empagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis.

The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging.

Null and alternative hypotheses:

H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Empagliflozin versus placebo.

H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Empagliflozin versus placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborator: Vienna Dialysis Center
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Age ≥18 years

• Maintenance hemodialysis 3×/week for ≥3 months and ≤3 years

• BMI <45 kg/m2 and stable weight (± 5 kg ["dry weight"]) over the preceding three months

• Signed informed consent

Exclusion Criteria:

Study specific:

• Contraindications for MRI

• Hypersensitivity or Intolerance of Empagliflozin

• Participation in another clinical trial

Medical condition specific:

• History of diabetic ketoacidosis

• Life expectancy < 1 year

• Substance abuse

• History of Type 1 diabetes mellitus

• Scheduled kidney transplant from a living donor

• Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.

• Acute coronary syndrome during the last 30 days

• Existing treatments with

• SGLT2i within the last 6 months

Female specific:

• Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).

• Pregnancy

• Breast feeding