Anthracycline-induced CardiotoxicityPhase 2SPARTACUSNCT07572175
Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity
A Phase 2 study testing Sotagliflozin in people with Anthracycline-induced Cardiotoxicity and Lymphoma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anthracycline-induced Cardiotoxicity, Lymphoma, Chemotherapy
- What is being tested?
- Sotagliflozin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Carlos G Santos-Gallego
About this study
Official title: SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
- Being tested
- Sotagliflozin, Placebo
- Keywords
- anthracycline, left ventricular dysfunction, cardiotoxicity, SGLT inhibitors, prevention
- Medical subject headings
- Lymphoma, Cardiotoxicity, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion
PlaceboDrug
Placebo starting prior to the first scheduled anthracycline infusion
| Study group | Role | What they receive |
|---|---|---|
| Sotagliflozin | Active comparator | Sotagliflozin 400mg per day orally Receives: Drug: Sotagliflozin |
| Placebo | Placebo comparator | Matching Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI
LVEF is a measure of contractility of the heart (strength of contraction). Normal values are between 55-65%. It is the most widely used parameter by physicians worldwide to measure cardiac contractility.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Secondary outcomes (8)
Longitudinal Strain of Left Ventricle (LV)
Longitudinal strain is the deformation of a material per unit length, defined as the ratio of change in length to the original length in the direction of an applied load. It measures how much an object stretches (tensile) or compresses (compressive) along its axis Longitudinal strain is an echocardiographic technique that quantifies the percentage of systolic shortening of the heart muscle from base to apex. It is a highly sensitive indicator of left ventricular function, detecting subclinical, early myocardial dysfunction (e.g., in cardio-oncology) often before the ejection fraction (LVEF) drops. Normal GLS values are typically >18%.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LVEF by 3D-Echocardiography
LVEF is a measure of contractility of the heart (strength of contraction). Normal values are between 55-65%. It is the most widely used parameter by physicians worldwide to measure cardiac contractility.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV Volumes by MRI
LV volumes measure how enlarged the heart is. Chemotherapy destroys cardiac muscle and enlarges the heart (ie. increases LV volumes). The higher the LV volumes, the more damage by chemotherapy.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV Mass by MRI
LV mass measures the amount of cardiac muscle. Chemotherapy destroys cardiac muscle. The lower the LV mass, the more damage by chemotherapy.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV Longitudinal Strains by MRI
Longitudinal strain is the deformation of a material per unit length, defined as the ratio of change in length to the original length in the direction of an applied load. It measures how much an object stretches (tensile) or compresses (compressive) along its axis Longitudinal strain is an echocardiographic technique that quantifies the percentage of systolic shortening of the heart muscle from base to apex. It is a highly sensitive indicator of left ventricular function, detecting subclinical, early myocardial dysfunction (e.g., in cardio-oncology) often before the ejection fraction (LVEF) drops. Normal GLS values are typically >18%.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
6-Minute Walk Test (6MWT)
The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
NT-ProBNP
NT-ProBNP is a plasma biomarker of cardiac stress, cardiac tension and severity of heart failure. The higher the NT-ProBNP level, the more severe the heart failure induced by chemotherapy.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Troponin I
Troponin I is a plasma biomarker of cardiac injury and cardiac damage. The higher the troponin levels, the more cardiac damage induced by chemotherapy.
Measured: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anthracycline-induced CardiotoxicityStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Carlos Santos-Gallego, Icahn School of Medicine at Mount Sinai
- Investigators
- Carlos G Santos-Gallego, MD, Principal investigator, Icahn School of Medicine at Mount SinaiSantos-Gallego, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572175
- Sponsor's protocol ID
- GCO 25-0408
- Acronym
- SPARTACUS
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)
- ClinicalTrials.gov ID
- NCT07572175
- Acronym / sponsor ID
- SPARTACUS / GCO 25-0408
- Keywords
- anthracycline, left ventricular dysfunction, cardiotoxicity, SGLT inhibitors, prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin | Active comparator | Drug: SotagliflozinSotagliflozin 400mg per day orally |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotagliflozinSotagliflozin 400mg starting prior to the first scheduled anthracycline infusion | Drug | Sotagliflozin |
| PlaceboPlacebo starting prior to the first scheduled anthracycline infusion | Drug | Placebo |
Primary outcome
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.
LVEF is a measure of contractility of the heart (strength of contraction). Normal values are between 55-65%. It is the most widely used parameter by physicians worldwide to measure cardiac contractility.
8 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos G Santos-Gallego, MD principal investigator
Icahn School of Medicine at Mount Sinai
Santos-Gallego, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotagliflozin in people with Anthracycline-induced Cardiotoxicity and Lymphoma, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos G Santos-Gallego, MD (212-241-8484, carlos.santos-gallego@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.