The goal of this clinical trial is to test dapagliflizone in Fabry patients. The main questions it aims to answer are: * Has 10 mg/d of dapagliflozin a positive effect on kidney functions of Fabry patients. * Has 10 mg/d of dapagliflozin a positive effect on heart functions in Fabry patients. Participants will be asked to * Sign an informed consent * Give a blood and urine samples * Be subjected to Echocardiography investigation * Take 10 mg/day Dapagliflizone Researchers will compare treatment to placebo groups to see if kidneys and heart functions will be improved in the treatment group better more than the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Forxiga® as an add-on treatment in patients with renal and/or cardiac association FD in an exploratory framework.
matched oral drug. Placebo tablet will have the same color, taste, smell and package as the verum tablet
Assess the change of eGFR in treatment months 6, 12 and at baseline
The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 2009 formula are used to evaluate the calculated GFR. eGFR in month 6 and 12 are compared to baseline eGFR.
Time frame: Baseline, 6 months and 12 months
Assess the change of Protein /creatinine ratio in urine
Total protein is measured in the morning sample of urine, minimal volume of 10 ml are collected and analyzed using Immune nephelometry method. Protein concentration are reported in relation to creatinine.
Time frame: Baseline, 6 months and 12 months
Assess the change of Albumin/creatinine ratio in urine
Albumin is measured in the morning sample of urine, minimal volume of 10 ml are collected and analyzed using Immune nephelometry method. Albumin concentration are reported in relation to creatinine.
Time frame: Baseline, 6 months and 12 months
NT-pro BNP level will be assessed at baseline and after 6 and 12 months of treatment with study drug and placebo
NT-pro BNP are assessed using a minimal of 2.5 ml heparin-plasma sample with Electro- Chemiluminescent Immunoassay technique.
Time frame: Baseline, 6 months and 12 months
Troponin I levels will be assessed at baseline and after 6 and 12 months of treatment with
Troponin I are measured in heparin whole blood (min. 2.5 ml) using Chemiluminescent Microparticle Immunoassay.
Time frame: Baseline, 6 months and 12 months
LVMMI parameter will be assessed at baseline and after 6 and 12 months of treatment with study drug and placebo
LVMMI parameter are assessed using M-mode echocardiography in Cardiology clinic
Time frame: Baseline, 6 months and 12 months
Septal thickness parameter will be assessed at baseline and after 6 and 12 months of treatment with study drug and placebo
Septal thickness parameter are assessed using M-mode echocardiography in Cardiology clinic
Time frame: Baseline, 6 months and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.