Vasodilators and Exercise as Adjuvant Therapy for Duchenne Muscular Dystrophy (VASO-REx Study)
Trial ID: NCT06290713
Interventional - Phase 2 - Recruiting
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.
Conditions
- Duchenne Muscular Dystrophy
- Duchenne Disease
- Muscular Dystrophy
- Muscular Dystrophy in Children
- Vasodilation
- Exercise
- DMD
Interventions
- Tadalafil
- Placebo
- Exercise Training
Eligibility
Inclusion criteria
- Diagnosis of DMD confirmed by genetic report
- Minimum entry age of 6.0 years old
- Ambulatory
- On stable glucocorticoid regimen (for \> 3 months)
Exclusion criteria
- 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
Sponsor
University of Florida, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Source: ClinicalTrials.gov
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