Duchenne Muscular Dystrophy study: SGLT-2 inhibitor vs SGLT2 inhibitor
Official title Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy
ClinicalTrials.gov ID: NCT07172971
What this study is testing
What is SGLT-2 inhibitor?
SGLT-2 inhibitor is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for duchenne muscular dystrophy (dmd).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18, men only
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.