Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

August 31, 2026

Conditions
Chronic Kidney Disease Requiring Hemodialysis
Interventions
DRUG

iSGLT2

"Participants randomized to the experimental arm will receive a once-daily dose of a sodium-glucose cotransporter 2 inhibitor (SGLT2i), administered orally, in addition to their standard hemodialysis care. The specific agent (e.g., dapagliflozin or empagliflozin) and dose will be selected based on safety data and clinical guidelines applicable to patients with end-stage renal disease (ESRD) on dialysis. The intervention will be maintained for 12 months. Dosing will be monitored by the research team to ensure tolerability and adherence. All patients in the experimental group will undergo comprehensive cardiovascular assessment, including serial cardiac MRI, echocardiography, and measurement of fibrosis-related biomarkers.~This intervention differs from standard care by introducing a pharmacologic agent not routinely administered in the dialysis population, targeting cardiac remodeling, fibrosis, and intradialytic complications."

Trial Locations (1)

C1431FWO

RECRUITING

Fresenius Medical Care - CEMIC Saavedra, Buenos Aires

All Listed Sponsors
lead

Maximo Agustin Schiavone

OTHER

NCT06929169 - Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study | Biotech Hunter | Biotech Hunter