Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-13
Brief Title:
Sodium Glucose Co-transporter SGLT Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Sodium Glucose Co-transporter SGLT Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOTA-CROSS HCM
Brief Summary:
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
1 Will sotagliflozin be well tolerated in patients with nonobstructive HCM
2 Will sotaglifozin improve exercise capacity diastolic dysfunction andor physical functioning in patients with nonobstructive HCM
3 Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM
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
1 Will sotagliflozin be well tolerated in patients with nonobstructive HCM
2 Will sotaglifozin improve exercise capacity diastolic dysfunction andor physical functioning in patients with nonobstructive HCM
3 Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61HL164376 | NIH | None | httpsreporternihgovquickSearchR61HL164376 |