SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)
Icahn School of Medicine at Mount Sinai
Summary
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Patients ≥ 18 years * Newly diagnosed lymphoma * Scheduled to receive high-dose anthracycline (cumulative dose ≥ 300 mg/m2) * Eastern Cooperative Oncology Group (ECOG) performance status 0-3 Exclusion Criteria * Prior anthracycline treatment * Previous malignancy requiring any chemotherapy or radiotherapy * Previous treatment with SGLT2i (eg due to T2DM) or SGLT1/2i * Previous heart failure (HF patients should already be on SGLT2i as per guidelines) * LVEF\<40% (even in the absence of HF): * Pregnancy or breastfeeding * Standard contraindication to MRI (claustrophobia,…
Interventions
- DrugSotagliflozin
Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion
- DrugPlacebo
Placebo starting prior to the first scheduled anthracycline infusion
Location
- Icahn School of Medicine at Mount SinaiNew York, New York