NCT05710367

Effects Of Sodium Glucose Cotranspoter 2 Inhibitors On Heart And Kidneys In Fabry Disease Patients

Effects Of Sodium Glucose Cotranspoter 2 Inhibitors On Heart And Kidneys In Fabry Disease Patients; A Prospective, Randomized, Double-Blind, Placebo- Controlled Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Albina Nowak, MD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fabry Disease

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab	Forxiga® as an add-on treatment in patients with renal and/or cardiac association FD in an exploratory framework.
DRUG	Placebo	matched oral drug. Placebo tablet will have the same color, taste, smell and package as the verum tablet

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-02-02
• Last updated: 2023-02-02