Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
Recruiting
Phase 1
Interventional Study
Duchenne Muscular Dystrophy (DMD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 8 – 18
- Sex
- Male
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 10 (estimated)
- Sponsor
- Vanderbilt University Medical Center · Other
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About This Trial
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 (absorp…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Current investigational …
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