Actively Recruiting

Phase 2
Age: 6Years +
MALE
NCT06290713

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

Age: 6Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Florida Clinical and Translational Research Building

Gainesville, Florida, United States, 32603

Actively Recruiting

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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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