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VASO-REx Study for Duchenne Muscular Dystrophy

This study, called VASO-REx, is exploring two potential ways to help boys with Duchenne Muscular Dystrophy (DMD) who can still walk. It's testing if a medication called tadalafil, which helps blood flow, combined with a home-based exercise program, can improve muscle function and overall health. The study aims to see if these approaches can help with muscle strength, endurance, and how well blood flows to muscles. To join, you must be a male at least 6 years old with a confirmed DMD diagnosis, able to walk, and on a stable glucocorticoid medication. The study will measure how well your blood vessels respond to tadalafil and how long you can cycle before getting tired. The current recruitment status is unclear, but the study plans to enroll 50 participants.

Study design
This is a randomized, double-blinded study, meaning participants will receive either tadalafil or a placebo, and neither you nor the study team will know which one you are receiving. The study plans to enroll 50 male participants.
What's involved
You would take either tadalafil or a placebo daily for 6 months and participate in weekly exercise sessions. The exercise involves individualized cycling up to four times a week, for up to 40 minutes each session.
Compensation
Not stated in the trial record.
Follow-up
Your vascular responsiveness will be measured up to 4 weeks after the completion of initial visits, and cycling time to fatigue will be measured at baseline and after 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06290713

Vasodilator and Exercise Study for DMD (VASO-REx)

Recruiting
PHASE2Ages 6+InterventionalTreatment
University of Florida
~50 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:TadalafilPlaceboExercise Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Vascular responsiveness after muscle contraction to a single dose of tadalafil.
Measured over up to 4 weeks after the completion of Visits 1 and 2 of Aim 1.
+1 more outcome measured

Conditions

Duchenne Muscular Dystrophy
Duchenne Disease
Muscular Dystrophy
Muscular Dystrophy in Children
Vasodilation
Exercise
DMD

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Duchenne Muscular Dystrophy

NCT06290713

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Florida Clinical and Translational Research Building

    Gainesville, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Tanja Taivassalo, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Florida, College of Medicine, Department of Physiology and Aging

Who to contact

Tanja Taivassalo, Ph.D.
[email protected]
352-294-8748
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of DMD confirmed by genetic report
Minimum entry age of 6.0 years old
Ambulatory
On stable glucocorticoid regimen (for \> 3 months)

Exclusion

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

What this trial measures

  • Vascular responsiveness after muscle contraction to a single dose of tadalafil.up to 4 weeks after the completion of Visits 1 and 2 of Aim 1.

    Responsiveness will be determined by an increase in post-contractile muscle oxygenation using MRI-Blood Oxygen Level Dependent (BOLD) responses after dosing compared to before. Study participants demonstrating an increase (\>50%) in post-contractile BOLD after tadalafil will be enrolled into Aim 2 of this study.

  • Cycling time to fatigueBaseline and 6 month follow-up visits of Aim 2.

    The study will assess the impact of tadalafil on exercise performance and fatigue resistance compared to placebo. Participants will undergo a maximal effort cycling test before and after the intervention period. The time it takes for participants to reach exhaustion (TTE) will be recorded as the primary outcome measure. Measurement: Time to exhaustion (TTE) during a maximal effort cycling test on a recumbent, stationary ergometer. This test will quantify fatigue resistance by measuring the duration participants can sustain maximal effort cycling.