Actively Recruiting
Vasodilator and Exercise Study for DMD (VASO-REx)
Led by University of Florida · Updated on 2025-07-09
50
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vasodilator and Exercise Study for DMD (VASO-REx)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Duchenne muscular dystrophy confirmed by genetic report
- At least 6 years old
- Able to walk (ambulatory)
- On a stable glucocorticoid regimen for more than 3 months
You will not qualify if you...
- Unable to undergo Magnetic Resonance Imaging (e.g., severe claustrophobia, magnetic implants, unwilling or unable to perform test)
- Having unstable medical problems including severe heart muscle disease, left ventricular ejection fraction below 45%, cardiac conduction abnormalities, uncontrolled seizures, or uncontrolled low or high blood pressure
- Having other medical conditions affecting muscle function or metabolism such as myasthenia gravis, endocrine disorders, or mitochondrial disease
- Having conditions causing developmental delay or impaired motor control like cerebral palsy or history of unprovoked muscle breakdown (rhabdomyolysis)
- Contraindications to phosphodiesterase 5 inhibitors such as use of nitrates, alpha-adrenergic blockers, or similar medications affecting blood flow or muscle metabolism
- Currently participating in other FDA-approved or investigational clinical trials during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida Clinical and Translational Research Building
Gainesville, Florida, United States, 32603
Actively Recruiting
Research Team
T
Tanja Taivassalo, Ph.D.
CONTACT
R
Ruby Sullivan, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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