Using dapagliflozin to improve heart health in kidney failure patients on hemodialysis
SGLT2 Inhibition (Dapagliflozin) in Diabetic and Non-diabetic Hemodialysis Patients With and Without Residual Urine Volume: a Prospective Randomized, Placebo-controlled, Double-blinded Phase II Trial
This study is testing if the medication dapagliflozin can help improve heart health in people with kidney failure who are on hemodialysis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05179668 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effects of the SGLT2 inhibitor dapagliflozin on cardiovascular outcomes in patients with kidney failure undergoing hemodialysis. Participants will be randomly assigned to receive either dapagliflozin or a placebo for six months, with the primary focus on changes in left ventricular mass as measured by cardiac magnetic resonance imaging. Secondary endpoints will include various cardiac and metabolic parameters, as well as monitoring of hospitalizations and mortality. The study aims to provide insights into the potential cardiovascular benefits of SGLT2 inhibition in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on maintenance hemodialysis for at least three months and meet specific health criteria.
Not a fit: Patients with contraindications for MRI, severe valvular heart disease, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and outcomes for patients with kidney failure on hemodialysis.
How similar studies have performed: While the use of SGLT2 inhibitors in other populations has shown promise, this specific application in hemodialysis patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Maintenance hemodialysis 3×/week for ≥3 months and ≤3 years * BMI \<45 kg/m2 and stable weight (± 5 kg \["dry weight"\]) over the preceding three months * Signed informed consent Exclusion Criteria: Study specific: * Contraindications for MRI * Hypersensitivity or Intolerance of SGLT2 inhibitors * Participation in another clinical trial Medical condition specific: * History of diabetic ketoacidosis * Interventricular septum width ≤ 11 mm * Severe valvular heart disease * Life expectancy \< 1 year * Substance abuse * History of Type 1 diabetes mellitus * Scheduled kidney transplant from a living donor * Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator. * Acute coronary syndrome during the last 30 days * Existing treatments with SGLT2i within the last 6 months Female specific: * Child bearing potential \& unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment). * Pregnancy * Breast feeding
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Principal investigator: Manfred Hecking, MD, PhD — Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis
- Study coordinator: Christopher Paschen, MD
- Email: christopher.paschen@meduniwien.ac.at
- Phone: 014040043910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.