Status:
RECRUITING
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Lead Sponsor:
Maximo Agustin Schiavone
Conditions:
Chronic Kidney Disease Requiring Hemodialysis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Patients with end-stage kidney disease (ESKD) on hemodialysis face an unacceptably high rate of cardiovascular complications, including heart failure, arrhythmias, and sudden cardiac death. Many of th...
Detailed Description
This is a Phase 2, prospective, randomized, open-label, controlled study designed to assess the safety and efficacy of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with end-stage ren...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤70 years
- Diagnosed with end-stage renal disease
- Undergoing online hemodiafiltration for at least 3 months
- Able to provide written informed consent
Exclusion
- Current immunosuppressive therapy
- Contraindication to cardiac MRI
- Known hypersensitivity or intolerance to SGLT2 inhibitors
- Participation in another interventional clinical trial
- History of diabetic ketoacidosis
- Active substance abuse
- Diagnosis of type 1 diabetes mellitus
- History of kidney transplantation
- Acute coronary event within 30 days before enrollment
- Current or recent treatment with an SGLT2 inhibitor
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06929169
Start Date
May 1 2025
End Date
August 1 2026
Last Update
April 16 2025
Active Locations (1)
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1
Fresenius Medical Care - CEMIC Saavedra
Buenos Aires, Buenos Aires, Argentina, C1431FWO