Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity

NCT07572175 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: GCO 25-0408
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anthracycline-induced Cardiotoxicity; Lymphoma; Chemotherapy; Cardiotoxicity

Keywords

anthracycline; left ventricular dysfunction; cardiotoxicity; SGLT inhibitors; prevention

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

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

• LVEF by 3D-Echocardiography

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

• LV Volumes by MRI

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

• LV Mass by MRI

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

• LV Longitudinal Strains by MRI

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

Study Arms (2)

Sotagliflozin

ACTIVE COMPARATOR

Sotagliflozin 400mg per day orally

Drug: Sotagliflozin

Placebo

PLACEBO COMPARATOR

Matching Placebo

Drug: Placebo

Interventions

Sotagliflozin DRUG

Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion

Sotagliflozin

Placebo DRUG

Placebo starting prior to the first scheduled anthracycline infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• American Heart Association: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Lymphoma; Cardiotoxicity; Ventricular Dysfunction, Left

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Ventricular Dysfunction

Study Officials

• Carlos G Santos-Gallego, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Santos-Gallego, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos G Santos-Gallego, MD

CONTACT

212-241-8484; carlos.santos-gallego@mssm.edu

Juan Antonio Requena-Ibanez

CONTACT

212-241-8484; juanantonio.requenaibanez@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Assistant Professor of Cardiology

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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).

Locations

US (1)