SGLT2 Inhibition in Hemodialysis

Phase 2Active Not RecruitingNCT05179668

Medical University of Vienna220 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

220

Conditions

Kidney Failure Hemodialysis Diabetes Mellitus, Type 2 Chronic Kidney Disease Left Ventricular Hypertrophy

Interventions

Dapagliflozin 10 MGDRUG

administered orally once daily

PlaceboDRUG

administered orally once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Dialyseinstitut Dr. Waller

Feldbach, Austria

Dialyseinstitut Gießauf GmbH

Graz, Austria

Klinik Landstraße

Vienna, Austria

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Change in left ventricular mass indexed to body surface area

Change in left ventricular mass indexed to body surface area using echocardiography

Time frame: 6 months

Secondary Outcomes

Change in left ventricular mass indexed to body height assessed by echocardiography

Time frame: 6 months

Change in LVEF assessed by echocardiography

Time frame: 6 months

Change in in LA volume index assessed by echocardiography

Time frame: 6 months

Change in in GLS assessed by echocardiography

Time frame: 6 months

Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)

Time frame: 6 months

Change in health-related quality of life

Time frame: 6 months

Change in LV end-diastolic volume assessed by echocardiography

Time frame: 6 months

Change in LV end-systolic volume assessed by echocardiography

Time frame: 6 months

Change in body weight

Time frame: 6 months

Change in blood pressure

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.