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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL164376 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are:
Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM).
Participants will:
Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks.
Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo first phase, Sotagliflozin second phase | Placebo Comparator | Matching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase |
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| Sotagliflozin first phase, Placebo second phase | Active Comparator | Sotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Adverse event reporting | Through study completion, 28 weeks |
| Intracavitary obstruction | Intracavitary left ventricular pressure gradient in mmHg | Through study completion, 28 weeks |
| Cardiac rhythm | New occurrence of cardiac arrhythmia measured by ambulatory monitoring | Through study completion, 28 weeks |
| Maximal exercise capacity | Peak oxygen consumption in mL/min | Through study completion, 28 weeks |
| Submaximal exercise capacity | Stroke volume augmentation at exercise steady state in mL/min | Through study completion, 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic function | Left ventricular ejection fraction in % measured by echocardiography | Through study completion, 28 weeks |
| Contractility | Global longitudinal strain in % measured by echocardiography |
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Inclusion Criteria:
7. Left ventricular ejection fraction > 50% by echocardiogram or cardiac MRI based on the most recent assessment in the past year prior to screening and confirmed during Visit 1 echocardiogram.
8. Stable medical therapy for at least 1 month prior to study enrollment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharlene Day, MD | Contact | 734-548-0394 | sharlene.day@pennmedicine.upenn.edu | |
| Kim Clinton | Contact | 215-431-4545 | kimberly.clinton@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sharlene Day, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
No individual participant data will be available to other researchers
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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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Double-blinded
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| Through study completion, 28 weeks |
| Diastolic function | E/E' ratio measured by echocardiography | Through study completion, 28 weeks |
| Left ventricular hypertrophy | Maximal left ventricular wall thickness in mm by echocardiography | Through study completion, 28 weeks |
| Symptom scores | Kansas City Living with Heart Failure (KCCQ) Clinical Summary Score, scale 0-100 with lower scores being worse | Through study completion, 28 weeks |
| Symptom scores and quality of life | Kansas City Living with Heart Failure (KCCQ) Overall Summary Score, score 0-100 with lower scores being worse | Through study completion, 28 weeks |
| Biomarkers | Serum levels of N-terminal-proBNP | Through study completion, 28 weeks |
| Circulating metabolites | Concentration of serum metabolites | Through study completion, 28 weeks |
| Measurement of periods of activity and rest | Daily step counts by actigraphy | Through study completion, 28 weeks |