NCT07172971
Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
Recruiting · Phase 1 · Vanderbilt University Medical Center · registry updated 2026-08-24
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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 to the mortality benefits seen in adult cardiomyopathy and heart failure. Investigators will perform PK studies in DMD patients of various ages and weights to better understand the PK profile (absorption, distribution, metabolism, excretion) and dosing to better treat Duchenne cardiomyopathy.
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