Tests SGLT2 inhibitors for heart health in people on dialysis
Tests an SGLT2 inhibitor drug against standard care in adults on hemodialysis.
Plain-language title generated from the registry record
Registry title: Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Key facts
- Where
- Buenos Aires, ArgentinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06929169, who can take part
Where in Argentina
- Fresenius Medical Care - CEMIC SaavedraBuenos Aires, ArgentinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maximo Agustin Schiavone
- Trial code
- NCT06929169
- Record updated
- 16 April 2025
- Original description
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 these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies. SGLT2 inhibitors, originally developed for the treatment of type 2 diabetes, have demonstrated cardiovascular and renal protective effects across multiple patient populations, independent of glycemic control.Read full original descriptionShow less
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
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 these outcomes are driven by diastolic dysfunction and cardiac fibrosis-conditions that are not adequately addressed by current therapies. SGLT2 inhibitors, originally developed for the treatment of type 2 diabetes, have demonstrated cardiovascular and renal protective effects across multiple patient populations, independent of glycemic control.
This Phase 2, randomized, controlled clinical trial will evaluate the safety and efficacy of SGLT2 inhibitors in patients undergoing maintenance hemodialysis. A total of 80 participants will be randomized to receive either an SGLT2 inhibitor or standard care for 12 months. The primary objective is to determine whether SGLT2 inhibitors improve cardiac function, reduce myocardial fibrosis, and decrease the incidence of intradialytic hypotension. Secondary endpoints include cardiovascular events, hospitalization, and all-cause mortality. The study will also assess changes in key biomarkers and perform advanced cardiac imaging to evaluate structural and functional outcomes.
This trial represents a novel and timely investigation into a class of medications with promising pleiotropic effects, potentially offering new therapeutic options for a high-risk, underserved population.
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; Acute coronary event within 30 days before enrollment; Current or recent treatment with an SGLT2 inhibitor; Contraindication to cardiac MRI; Known hypersensitivity or intolerance to SGLT2 inhibitors; History of diabetic ketoacidosis; Diagnosis of type 1 diabetes mellitus; History of kidney transplantation; Participation in another interventional clinical trial; Active substance abuse.