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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 220
- Locations
- 9
- Primary Endpoint
- Change in left ventricular mass indexed to body surface area
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Dapagliflozin 10 mg
Intervention: Dapagliflozin 10 MG (Drug)
Placebo tablet
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in left ventricular mass indexed to body surface area
Time Frame: 6 months
Change in left ventricular mass indexed to body surface area using echocardiography
Secondary Outcomes
- Change in left ventricular mass indexed to body height 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 LVEF assessed by echocardiography(6 months)
- Change in in LA volume index assessed by echocardiography(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)
Investigators
Assoc. Prof. Dr. Manfred Hecking, MD PhD
Principal Investigator
Medical University of Vienna