Actively Recruiting
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Led by Maximo Agustin Schiavone · Updated on 2025-04-16
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with end-stage kidney disease undergoing maintenance hemodialysis. Cardiovascular complications such as heart failure, arrhythmias, and sudden cardiac death are common in this group, often linked to diastolic dysfunction and cardiac fibrosis that current treatments do not adequately address. This Phase 2 randomized controlled trial seeks to determine if SGLT2 inhibitors can improve cardiac function and reduce these risks. Participants will be randomly assigned to one of two groups: one receiving standard hemodialysis care without SGLT2 inhibitors, and the other receiving a once-daily oral SGLT2 inhibitor alongside standard care for 12 months. The intervention group will be monitored through advanced cardiac imaging and biomarker assessments at baseline and at 3, 6, and 12 months. The study will assess changes in heart structure and function, myocardial fibrosis, and the frequency of intradialytic hypotension. Throughout the 12-month study, participants will undergo comprehensive evaluations including echocardiography, cardiac MRI, 24-hour heart rhythm monitoring, and laboratory tests. Researchers will track cardiovascular events, hospitalizations, and mortality. Data will be collected at multiple time points to measure outcomes such as changes in left ventricular mass and ejection fraction, fibrosis biomarkers, and incidence of hypotension during dialysis. This thorough monitoring aims to provide new insights into cardiac health in dialysis patients.
CONDITIONS
Brief Title
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Diagnosed with end-stage renal disease
- Undergoing online hemodiafiltration for at least 3 months
- Able to provide written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive either a once-daily oral SGLT2 inhibitor in addition to standard hemodialysis care or continue standard care alone. Cardiovascular assessments including cardiac MRI, echocardiography, and biomarker measurements are performed to monitor effects on cardiac function and fibrosis.
Baseline visit and follow-up visits at months 3, 6, and 12
Trial Site Locations
Total: 1 location
1
Fresenius Medical Care - CEMIC Saavedra
Buenos Aires, Buenos Aires, Argentina, C1431FWO
Actively Recruiting
Research Team
M
Maximo A Schiavone, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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