SGLT-2 Inhibitor Therapy for Duchenne Cardiomyopathy

This study is looking at how a medication called an SGLT-2 inhibitor (specifically empagliflozin) works in boys with Duchenne Muscular Dystrophy (DMD). We know that heart problems (cardiomyopathy) are a major concern for people with DMD. Empagliflozin is already used for heart conditions in adults, and this study aims to understand the best dose for children and teenagers with DMD. Researchers will study how the body absorbs, distributes, uses, and gets rid of the medication. You may be able to join if you are a boy between 8 and 18 years old with DMD, have signs of heart scarring (late gadolinium enhancement) on a heart MRI, and your heart function is normal or only mildly reduced. The study plans to enroll 10 participants to understand the medication's dose over 12 months.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a pharmacokinetic study, focusing on how the body handles the drug, and plans to enroll 10 male participants.
What's involved
Participants will receive an SGLT-2 inhibitor once daily by mouth. The study will track medication dose from enrollment up to a 12-month analysis.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment up to a 12-month analysis.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07172971

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

Recruiting
PHASE1Ages 8–18Interventional
Vanderbilt University Medical Center
~10 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:SGLT-2 inhibitorSGLT2 inhibitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Medication dose
Measured over From enrollment to 12 month analysis
Duchenne Muscular Dystrophy (DMD)

NCT07172971

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Vanderbilt University Medical Center

    Nashville, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Larry W. Markham, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Eligibility criteria

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
  • Medication doseFrom enrollment to 12 month analysis

    DMD patients will be given different doses of medication to better understand the most appropriate dosing of medication in this rare disease population. Because age and weight can impact how a DMD patient absorbs and metabolizes medication, the study will include DMD patients of various ages and weights. This includes giving a dose of medication and measuring drug levels in blood over a 24 hour period of time.