Clinical trial · Interventional
Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity
SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)
NCT07572175CI-TRIAL-00110813SPARTACUSnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anthracycline-induced Cardiotoxicity | — | UNRESOLVED | — |
| Cardiotoxicity | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Sotagliflozin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sotagliflozin
- description
- Sotagliflozin 400mg per day orally
- interventionNames
- Drug: Sotagliflozin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Matching Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI
- timeFrame
- Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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, non-MRI compatible devices)
References
Publications (0)
Data not yet available
No reference posted for this study.