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Design, rationale, and baseline characteristics of the dapagliflozin in haemodialysis (DAPA-HD) trial
Thomas A Zelniker1, Christopher Paschen2, Christopher Mann1
1Division of Cardiology, Department of Medicine II, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria.
Insights
The Dapagliflozin in Hemodialysis (DAPA-HD) trial investigates cardiovascular effects of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in hemodialysis patients. This study addresses a critical gap in understanding SGLT2i benefits for kidney failure patients.
Area of Science:
- Nephrology
- Cardiology
- Pharmacology
Background:
- Sodium-glucose co-transporter 2 inhibitors (SGLT2i) show cardiovascular benefits in chronic kidney disease, but efficacy in end-stage kidney disease patients on hemodialysis is unproven.
- Mechanisms of SGLT2i cardiovascular benefits and their dependence on residual kidney function are not fully understood.
Purpose of the Study:
- To evaluate the cardiovascular effects of dapagliflozin in patients with kidney failure undergoing maintenance hemodialysis.
- To investigate whether residual kidney function influences the cardiovascular benefits of dapagliflozin.
Main Methods:
- The Dapagliflozin in Hemodialysis (DAPA-HD) trial is a randomized, double-blind, placebo-controlled study involving 220 hemodialysis patients.
- Primary endpoint: change in left ventricular mass indexed to body surface area after six months.
- Subgroup analysis based on residual urine output (>200 mL/24 hours vs. ≤200 mL/24 hours).
Main Results:
- N/A - Trial results are pending.
Conclusions:
- The DAPA-HD trial is the first to specifically assess dapagliflozin's cardiovascular and hemodynamic impact in hemodialysis patients.
- Findings will clarify SGLT2i efficacy and potential benefits in the kidney failure population, with or without residual urine output.
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.
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