Design, rationale, and baseline characteristics of the dapagliflozin in haemodialysis (DAPA-HD) trial.

INTRODUCTION

Sodium-glucose co-transporter 2 inhibitors (SGLT2i) reduce cardiovascular events across a wide range of kidney function, including advanced stages of chronic kidney disease, but evidence for their efficacy in patients with kidney failure on haemodialysis is lacking. The underlying mechanisms remain incompletely understood, and whether cardiovascular benefits depend on residual kidney function is unknown.

STUDY

DESIGN

The Dapagliflozin in Hemodialysis (DAPA-HD) trial (NCT05179668) is an academic, multicentre, randomized, double-blind, placebo-controlled trial designed to assess the cardiovascular effects of dapagliflozin in 220 patients with kidney failure receiving haemodialysis. Stratified block randomization was based on patient-reported residual urine volume. The primary endpoint is the change in left ventricular mass indexed to body surface area using echocardiography after 6 months of treatment. A prespecified subgroup analysis will compare treatment effects between patients with residual urine output >200 ml/24 h versus ≤200 ml/24 h. Secondary endpoints include additional echocardiographic assessments, changes in biomarker concentrations, quality of life, and clinical events.

DISCUSSION: The DAPA-HD trial is the first trial specifically evaluating the cardiovascular and haemodynamic effects of dapagliflozin in patients with kidney failure receiving maintenance haemodialysis with and without residual urine outputs.