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The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear.
The present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotagliflozin | Experimental | Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months. |
|
| Placebo | Placebo Comparator | Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Left Ventricular Mass in CMRI | Changes in Left Ventricular (LV) mass at 6 months compared to baseline | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Left Ventricular End-systolic Volume | Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline | Baseline and 6 months |
| Changes in Left Ventricular End-diastolic Volume |
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Inclusion Criteria: patients should meet all of the following criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan J Badimon | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Carlos G 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37318685 | Derived | Perez MS, Rodriguez-Capitan J, Requena-Ibanez JA, Santos-Gallego CG, Urooj Zafar M, Escolar G, Mancini D, Mitter S, Lam D, Contreras JP, Fergus I, Atallah-Lajam F, Abascal V, Lala A, Moreno P, Moss N, Lerakis S, Sanz J, Fuster V, Badimon JJ. Rationale and Design of the SOTA-P-CARDIA Trial (ATRU-V): Sotagliflozin in HFpEF Patients Without Diabetes. Cardiovasc Drugs Ther. 2025 Feb;39(1):155-164. doi: 10.1007/s10557-023-07469-6. Epub 2023 Jun 15. |
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Undecided: It is not yet known if there will be a plan to make IPD available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotagliflozin | Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months. |
| FG001 | Placebo | Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sotagliflozin | Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months. |
| BG001 | Placebo | Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Left Ventricular Mass in CMRI | Changes in Left Ventricular (LV) mass at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | grams | Baseline and 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotagliflozin | Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juan Badimon | Icahn School of Medicine at Mount Sinai | (212) 241-8484 | juan.badimon@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2026 | May 26, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2025 | May 26, 2026 | ICF_001.pdf |
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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 | Matching placebo for 6 months. |
|
Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline
| Baseline and 6 months |
| Changes in Extracellular Volume (ECV) | Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline | Baseline and 6 months |
| Changes in Left Atrial Volume Index | Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline | Baseline and 6 months |
| Changes in Peak Oxygen Consumption (peakVO2) | Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline | Baseline and 6 months |
| Changes 6 Minute Walk Test | Changes in exercise tolerance as assessed by 6 minute walk test, or the distance covered over a time of 6 minutes, at 6 months compared to baseline | Baseline and 6 months |
| Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ) | Changes in The KCCQ at 6 months compared to baseline. The KCCQ is the most widely used instrument to evaluate quality of life in Heart Failure (HF). The KCCQ is a 12-item self-administered questionnaire used to measure the patient's perception of their health status. The KCCQ is a disease-specific health status instrument composed of 12 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Full scale range is from 0 to 100; higher scores reflect better health status. | Baseline and 6 months |
| withdrew consent prior to intervention |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Changes in Left Ventricular End-systolic Volume | Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | mL | Baseline and 6 months |
|
|
|
| Secondary | Changes in Left Ventricular End-diastolic Volume | Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline | Posted | Mean | 95% Confidence Interval | mL | Baseline and 6 months |
|
|
|
| Secondary | Changes in Extracellular Volume (ECV) | Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline | Not Posted | Baseline and 6 months | Participants |
| Secondary | Changes in Left Atrial Volume Index | Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline | Not Posted | Baseline and 6 months | Participants |
| Secondary | Changes in Peak Oxygen Consumption (peakVO2) | Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline | Not Posted | Baseline and 6 months | Participants |
| Secondary | Changes 6 Minute Walk Test | Changes in exercise tolerance as assessed by 6 minute walk test, or the distance covered over a time of 6 minutes, at 6 months compared to baseline | Not Posted | Baseline and 6 months | Participants |
| Secondary | Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ) | Changes in The KCCQ at 6 months compared to baseline. The KCCQ is the most widely used instrument to evaluate quality of life in Heart Failure (HF). The KCCQ is a 12-item self-administered questionnaire used to measure the patient's perception of their health status. The KCCQ is a disease-specific health status instrument composed of 12 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Full scale range is from 0 to 100; higher scores reflect better health status. | Not Posted | Baseline and 6 months | Participants |
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Placebo | Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months. | 0 | 41 | 0 | 41 | 0 | 41 |
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