SGLT2 Inhibition in Hemodialysis (DAPA-HD)

SGLT2 Inhibition (Dapagliflozin) in Diabetic and Non-diabetic Hemodialysis Patients With and Without Residual Urine Volume: a Prospective Randomized, Placebo-controlled, Double-blinded Phase II Trial

Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Hemodialysis; Chronic Kidney Disease; Kidney Failure; Left Ventricular Hypertrophy
• Intervention / Treatment: Drug: Placebo; Drug: Dapagliflozin 10 MG

Detailed Description

The Dapagliflozin in Hemodialysis (DAPA-HD) trial is an academic, multicenter, randomized, double-blind, placebo-controlled phase 2 study designed to assess the cardiovascular effects of dapagliflozin in patients with kidney failure undergoing maintenance hemodialysis. A total of 220 patients are randomized 1:1 to dapagliflozin 10 mg once daily or matching placebo for six months, with stratification according to residual urine output. The primary endpoint is the change in left ventricular mass indexed to body surface area, assessed by transthoracic echocardiography after six months of treatment. Secondary endpoints include additional echocardiographic measures, biomarker changes, quality of life, clinical events, and safety outcomes.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Feldbach, Austria, 8330
    • Dialyseinstitut Dr. Waller
  • Graz, Austria
    • Dialyseinstitut Gießauf GmbH
  • Vienna, Austria, 1090
    • Medical University of Vienna
  • Vienna, Austria, 1130
    • Krankenhaus Hietzing
  • Vienna, Austria, 1100
    • Klinik Favoriten
  • Vienna, Austria, 1030
    • Klinik Landstrasse
  • Vienna, Austria, 1140
    • Hanusch Krankenhaus
  • Vienna, Austria, 1220
    • Wiener Dialysezentrum
  • Vienna, Austria, 1220
    • Klinik Donaustadt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
• BMI <45 kg/m2 and stable weight (±5 kg ["dry weight"]) over the preceding three months
• Interventricular septum width >11 mm

Exclusion Criteria:

• Treatment with SGLT2i within the last 6 months
• Hypersensitivity or Intolerance of SGLT2 inhibitors
• History of Type 1 diabetes mellitus
• History of diabetic ketoacidosis
• Scheduled kidney transplant from a living donor
• Acute coronary syndrome during the last 30 days
• Severe valvular heart disease
• Women of childbearing potential and unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
• Pregnancy
• Breast feeding
• Substance abuse
• Life expectancy < 1 year
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo tablet	Drug: Placebo; administered orally once daily
Experimental: Dapagliflozin 10 mg	Drug: Dapagliflozin 10 MG; administered orally once daily; Other Names: Forxiga 10 MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular mass indexed to body surface area	Change in left ventricular mass indexed to body surface area using echocardiography	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in blood pressure	6 months
Change in left ventricular mass indexed to body height assessed by echocardiography	6 months
Change in LVEF assessed by echocardiography	6 months
Change in in LA volume index assessed by echocardiography	6 months
Change in in GLS assessed by echocardiography	6 months
Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)	6 months
Change in health-related quality of life	6 months
Change in LV end-diastolic volume assessed by echocardiography	6 months
Change in LV end-systolic volume assessed by echocardiography	6 months
Change in body weight	6 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Vienna Dialysis Center
• Investigators: Principal Investigator: Manfred Hecking, MD, PhD, Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis; Principal Investigator: Thomas A Zelniker, MD, MSc, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): July 11, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dapagliflozin; SGLT2 inhibition
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Cardiomegaly; Hypertrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Renal Insufficiency; Renal Insufficiency, Chronic; Hypertrophy, Left Ventricular; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; dapagliflozin
• Other Study ID Numbers: EK-Nr.: 1196/2021; 2021-000733-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No