Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07572175
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anthracycline-induced Cardiotoxicity
  • Cardiotoxicity
  • Chemotherapy
  • Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin — DRUG
    Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion
  • Placebo — DRUG
    Placebo starting prior to the first scheduled anthracycline infusion

Study Details

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

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Sotagliflozin
    Sotagliflozin 400mg per day orally
  • Placebo Comparator: Placebo
    Matching Placebo

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Carlos G Santos-Gallego (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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