Tests how the drug empagliflozin is processed in children with Duchenne muscular dystrophy
Studies empagliflozin dosing in boys aged 8 to 18 with Duchenne muscular dystrophy.
Plain-language title generated from the registry record
Registry title: Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
Key facts
- Where
- Nashville, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 18 years old?
Source: NCT07172971, who can take part
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vanderbilt University Medical Center
- Trial code
- NCT07172971
- Record updated
- 24 August 2026
- Original description
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.Read full original descriptionShow less
duCHennE caRdiomyopathy mItigation Sglt2 inHibitor
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; Renal disease or history of frequent urinary tract infections or genitourinary skin infections.