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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotagliflozin | Active Comparator | Sotagliflozin 400mg per day orally |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
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).
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D066126 | Cardiotoxicity |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
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| Placebo | Drug | Placebo starting prior to the first scheduled anthracycline infusion |
|
| 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. | 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. | 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. | 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%. | 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. | 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. | 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. | Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months. |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D018754 | Ventricular Dysfunction |