SGLT2 Inhibition in Hemodialysis (NCT05179668) | Clinical Trial Compass
CompletedPhase 2
SGLT2 Inhibition in Hemodialysis
Austria220 participantsStarted 2022-10-01
Plain-language summary
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years
* Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
* BMI \<45 kg/m2 and stable weight (±5 kg \["dry weight"\]) over the preceding three months
* Interventricular septum width \>11 mm
Exclusion Criteria:
* Treatment with SGLT2i within the last 6 months
* Hypersensitivity or Intolerance of SGLT2 inhibitors
* History of Type 1 diabetes mellitus
* History of diabetic ketoacidosis
* Scheduled kidney transplant from a living donor
* Acute coronary syndrome during the last 30 days
* Severe valvular heart disease
* Women of childbearing potential and unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
* Pregnancy
* Breast feeding
* Substance abuse
* Life expectancy \< 1 year
* 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.
What they're measuring
1
Change in left ventricular mass indexed to body surface area