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Clinical Trial 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.

Clinical Trial Description

The parallel groups will receive empagliflozin 10 mg vs. placebo (1:1 manner; n = 54 per group) for 6 months. Cardiological outcome parameters will include the change in left ventricular mass (LVM), left ventricular ejection fraction (EF), cardiac fibrosis and left atrial diameter (LAD) from baseline to 6 months measured by cMRI and strain echocardiography. Biochemical data will be collected prior to hemodialysis at baseline and periodically (e.g. blood gas analysis at every dialysis visit, measurements of and pre- and post- dialysis troponin T (TnT) and pro brain natriuretic peptide (proBNP) every 4 weeks). A full laboratory analysis of blood cell count, blood coagulation and clinical chemistry will be performed at baseline, 3 months, and 6 months. Additionally, body weight will be measured at all study visits to monitor changes after SGLT2 inhibitor administration. Hospitalizations and mortality will be monitored clinically. Further secondary endpoints are glucometabolic parameters (HbA1c, plasma values of insulin, c-peptide, glucagon, glucagon-Like peptide-1 (GLP1), cortisol, growth hormone, alanine, β-hydroxybutyrate (βOHB) [=ketone] and pyruvate concentration) and will be determined at baseline, 3 and 6 months. The HOMA-Indices will be calculated with the values of insulin and fasting glucose for monitoring of diabetes performed at baseline, 3 months, and 6 months. Volume status and fluid composition will be measured by bioimpedance spectroscopy at the baseline, 3 months, and end-of-study-visit. In case of hypervolemia, ultrafiltration parameters will be adapted to reach a dry weight based in synopsis of clinical status and body composition monitoring results. In terms of urinary output and tubuloglomerular feedback, a stratification by residual urine volume by 200 mL per day will be performed to elucidate study aim IV. Prior results of diabetes independent renal and cardiovascular benefit legitimate an examination of groups with and without prevalent diabetes mellitus. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05179668
Study type Interventional
Source Medical University of Vienna
Contact Christopher Paschen, MD
Phone 014040043910
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date March 1, 2022
Completion date February 28, 2025

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