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Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy

RecruitingPhase 1Ages 8 Years - 18 YearsMaleVanderbilt University Medical Center
NCT07172971 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 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
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What it tests

  • SGLT-2 inhibitor
  • SGLT2 inhibitor
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Where

1 site
Vanderbilt University Medical Center
Nashville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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