Status:
NOT_YET_RECRUITING
Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
Lead Sponsor:
Larry W. Markham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Duchenne Muscular Dystrophy (DMD)
Eligibility:
MALE
8-18 years
Phase:
PHASE1
Brief Summary
This is a pharmacokinetic study (PK Study) to better understand empagliflozin dosing in pediatric Duchenne muscular dystrophy patients. Empagliflozin is currently used off-label in this population due...
Detailed Description
Duchenne muscular dystrophy (DMD) is an X-linked skeletal and cardiac myopathy resulting from a defect in the gene coding for dystrophin. DMD myopathy leads to loss of ambulation, respiratory failure,...
Eligibility Criteria
Inclusion
- Clinical phenotype of DMD confirmed with muscle biopsy or genotype
- Presence of late gadolinium enhancement (LGE) imaging by CMR
- Either normal or mildly depressed systolic function (LVEF\>40%)
- ≥8 years old and ≤18 years old
Exclusion
- Current investigational therapy that may affect cardiovascular function
- Additional genetic or congenital abnormality that may affect cardiovascular function or progression
- Contraindication to or inability to undergo CMR
- Symptomatic heart failure
- History of ketoacidosis or hypersensitivity to SGLT2i therapy
- Type 1 diabetes
- Renal disease or history of frequent urinary tract infections or genitourinary skin infections
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07172971
Start Date
February 1 2026
End Date
February 1 2028
Last Update
December 24 2025
Active Locations (1)
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1
Riley Hospital at Indiana University Health
Indianapolis, Indiana, United States, 46202