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NCT Number: NCT07572175

Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity

This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sotagliflozin

Drug

Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion

Placebo

Drug

Placebo starting prior to the first scheduled anthracycline infusion

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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%.

  2. LVEF by 3D-Echocardiography

    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.

  3. LV Volumes by MRI

    Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

    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.

  4. LV Mass by MRI

    Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

    LV mass measures the amount of cardiac muscle. Chemotherapy destroys cardiac muscle. The lower the LV mass, the more damage by chemotherapy.

  5. LV Longitudinal Strains by MRI

    Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

    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%.

  6. 6-Minute Walk Test (6MWT)

    Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

    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.

  7. NT-ProBNP

    Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

    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.

  8. Troponin I

    Time frame: Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

    Troponin I is a plasma biomarker of cardiac injury and cardiac damage. The higher the troponin levels, the more cardiac damage induced by chemotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Carlos G Santos-Gallego, MD

CONTACT

[email protected]

212-241-8484

Juan Antonio Requena-Ibanez

CONTACT

[email protected]

212-241-8484

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: SPARTACUS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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