A Phase 2 interventional study of Sotagliflozin and Placebo in Anthracycline-induced Cardiotoxicity, Lymphoma and Chemotherapy, sponsored by Icahn School of Medicine at Mount Sinai. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 2, Interventional, and Prevention
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 60 is above the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sotagliflozin 400mg per day orally
Drug: Sotagliflozin
Matching Placebo
Drug: Placebo
Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion
Placebo starting prior to the first scheduled anthracycline infusion
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.
Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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%.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 9 months and ending 36 months following article publication.
Access criteria: Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jun 2029, 35 months later.
Of 237 non-industry phase 2 interventional studies under Lymphoma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 114. This study's planned 35 months is below that.
Counting every sponsor, half of 293 studies reached it within 61 months; a quarter within 36 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sotagliflozin
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