Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Sotagliflozin
DrugSotagliflozin 400mg starting prior to the first scheduled anthracycline infusion
Placebo
DrugPlacebo starting prior to the first scheduled anthracycline infusion
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: SotagliflozinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Icahn School of Medicine at Mount Sinai
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: