NCT07172971 Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
| NCT ID | NCT07172971 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Duchenne Muscular Dystrophy (DMD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-07-01 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Larry W. Markham, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07172971 clinical trial?
This trial is open to male participants only, aged 8 Years or older, up to 18 Years, studying Duchenne Muscular Dystrophy (DMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07172971 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07172971 currently recruiting?
Yes, NCT07172971 is actively recruiting participants. Contact the research team at larry.w.markham@vumc.org for enrollment information.
Where is the NCT07172971 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07172971 clinical trial?
NCT07172971 is sponsored by Vanderbilt University Medical Center. The principal investigator is Larry W. Markham, MD at Vanderbilt University Medical Center. The trial plans to enroll 10 participants.