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

Recruiting now · Phase 1

Conditions studied: Duchenne Muscular Dystrophy (DMD)

In brief

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.

Key facts

Study ID

NCT07172971

Run by

Vanderbilt University Medical Center

People needed

10

Starts

2026-07-01

Expected to finish

2028-02-01

Last updated by the study team

2026-07-21

Who can join

Age: 8 and older, up to 18. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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