Vasodilator and Exercise Study for DMD (VASO-REx)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Duchenne Muscular Dystrophy, Duchenne Disease, Muscular Dystrophy, Muscular Dystrophy in Children, Vasodilation, Exercise, DMD
In brief
Examining two strategies as potential adjuvant therapies for Duchenne muscular dystrophy (DMD); aerobic exercise training (to induce adaptations in skeletal muscle and improve cardiovascular health) and tadalafil, an FDA-approved vasodilator (to optimize blood flow and muscle perfusion which is impaired and often overlooked in DMD). Target: improved muscle function, vascular health, and DMD treatment.
Key facts
- Study ID
- NCT06290713
- Run by
- University of Florida
- People needed
- 50
- Starts
- 2024-06-05
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 6 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of DMD confirmed by genetic report
- Minimum entry age of 6.0 years old
- Ambulatory
- On stable glucocorticoid regimen (for > 3 months)
You may not qualify if…
- Contraindication to a Magnetic resonance Imaging examination (e.g. severe claustrophobia, magnetic implants, unable/unwilling to perform test)
- Presence of unstable medical problems, including severe cardiomyopathy, left ventricular ejection fraction <45%, cardiac conduction abnormalities as evidenced on ECG, uncontrolled seizure disorder, uncontrolled hypo or hypertension
- Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g., myasthenia gravis, endocrine disorder, mitochondrial disease)
- Presence of a secondary condition leading to developmental delay or impaired motor control (e.g., cerebral palsy) or previous history of unprovoked rhabdomyolysis
- Contraindications to phosphodiesterase 5 inhibitors (use of nitrates, alpha-adrenergic blockers, other phosphodiesterase 5 inhibitors) or other medications known to modulate blood flow or muscle metabolism
- Participation in currently approved FDA trials or other investigational clinical trials during the period of the study
Where it is running
- University of Florida Clinical and Translational Research Building — Gainesville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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