Chronic Kidney Disease, Diabetes Mellitus, Type 2, Hemodialysis, Kidney Failure, Left Ventricular Hypertrophy
Conditions
Keywords
Dapagliflozin, SGLT2 inhibition
Brief summary
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.
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.
Interventions
DRUGDapagliflozin 10 MG
administered orally once daily
DRUGPlacebo
administered orally once daily
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular mass indexed to body surface area | 6 months | Change in left ventricular mass indexed to body surface area using echocardiography |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in blood pressure | 6 months |
Countries
Austria
Contacts
PRINCIPAL_INVESTIGATORManfred Hecking, MD, PhD
Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis
PRINCIPAL_INVESTIGATORThomas A Zelniker, MD, MSc
Medical University of Vienna
Outcome results
None listed