NCT06929169RecruitingPhase 2
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- May 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- Maximo Agustin Schiavone
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT06929169
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From May 2025 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current immunosuppressive therapy
- Acute coronary event within 30 days before enrollment
- Current or recent treatment with an SGLT2 inhibitor
Other illness
- 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
Other
- Participation in another interventional clinical trial
- Active substance abuse
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fresenius Medical Care - CEMIC Saavedra Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.