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

Detailed criteria

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

Drug
Sotagliflozin
Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion
Drug
Placebo
Placebo starting prior to the first scheduled anthracycline infusion

Location

Icahn School of Medicine at Mount Sinai
New York, New York

SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions