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

duCHennE caRdiomyopathy mItigation Sglt2 inHibitor

Who can join

Ages 8 to 18 · Men

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

About the study

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.

What is being tested

• SGLT-2 inhibitor (drug)
• SGLT2 inhibitor (drug)

Sponsor: Vanderbilt University Medical Center · Participants: 10 · Started: Jul 1, 2026

Contact the study team

• Larry W Markham, MD · Phone: 615 322-7447
• Jennifer B Nicotera, RN · Phone: 615 322-7447

Official record on ClinicalTrials.gov — NCT07172971

Locations in the U.S.

Conditions

• Duchenne Muscular Dystrophy
• Cardiomyopathy
• Heart Failure
• Muscular Dystrophy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.