Not yet recruiting NCT07572175
Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sotagliflozin, Placebo.
- Who it may be relevant to
- Registry conditions: Anthracycline-induced Cardiotoxicity, Lymphoma, Chemotherapy, Cardiotoxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)
Overview
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
Interventions
- Drug Sotagliflozin
Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion - Drug Placebo
Placebo starting prior to the first scheduled anthracycline infusion
Primary outcome measures
- Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
Secondary outcome measures (8)
- Longitudinal Strain of Left Ventricle (LV) [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- LVEF by 3D-Echocardiography [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- LV Volumes by MRI [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- LV Mass by MRI [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- LV Longitudinal Strains by MRI [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- 6-Minute Walk Test (6MWT) [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- NT-ProBNP [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
- Troponin I [Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.]
Eligibility 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, non-MRI compatible devices)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT07572175 · GCO 25-0408