Diabetes Mellitus, Type 2 Clinical Trial
— DAPA-HDOfficial title:
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
The study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor dapagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis. The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging. Null and alternative hypotheses: H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo. H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | September 30, 2025 |
Est. primary completion date | April 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Maintenance hemodialysis 3×/week for =3 months and =3 years - BMI <45 kg/m2 and stable weight (± 5 kg ["dry weight"]) over the preceding three months - Signed informed consent Exclusion Criteria: Study specific: - Contraindications for MRI - Hypersensitivity or Intolerance of SGLT2 inhibitors - Participation in another clinical trial Medical condition specific: - History of diabetic ketoacidosis - Interventricular septum width = 11 mm - Severe valvular heart disease - Life expectancy < 1 year - Substance abuse - History of Type 1 diabetes mellitus - Scheduled kidney transplant from a living donor - 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. - Acute coronary syndrome during the last 30 days - Existing treatments with SGLT2i within the last 6 months Female specific: - Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment). - Pregnancy - Breast feeding |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna | Vienna Dialysis Center |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ? Left ventricular mass indexed to body surface area | measured by cMRI | From baseline to 6 months | |
Secondary | ? HbA1c [%] | Change in relative % | From baseline to 6 months | |
Secondary | ? Left ventricular mass indexed to body height | measured by cMRI | From baseline to 6 months | |
Secondary | ? Left ventricular ejection fraction | measured by cMRI | From baseline to 6 months | |
Secondary | ? Cardiac fibrosis | measured by cMRI | From baseline to 6 months | |
Secondary | ? Body weight [kg] | Change in kg | From baseline to 6 months |
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