RECRUITING

Vasodilator and Exercise Study for DMD (VASO-REx)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vasodilators and Exercise as Adjuvant Therapy for Duchenne Muscular Dystrophy (VASO-REx Study)

Quick Facts

Study Start:2024-06-05
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06290713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of DMD confirmed by genetic report
  2. * Minimum entry age of 6.0 years old
  3. * Ambulatory
  4. * On stable glucocorticoid regimen (for \> 3 months)
  1. * Contraindication to a Magnetic resonance Imaging examination (e.g. severe claustrophobia, magnetic implants, unable/unwilling to perform test)
  2. * 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
  3. * Presence of a secondary condition that impacts muscle function or muscle metabolism (e.g., myasthenia gravis, endocrine disorder, mitochondrial disease)
  4. * Presence of a secondary condition leading to developmental delay or impaired motor control (e.g., cerebral palsy) or previous history of unprovoked rhabdomyolysis
  5. * 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
  6. * Participation in currently approved FDA trials or other investigational clinical trials during the period of the study

Contacts and Locations

Study Contact

Tanja Taivassalo, Ph.D.
CONTACT
352-294-8748
ttaivassalo@ufl.edu
Ruby Sullivan, MS
CONTACT
352-294-5392
r.sullivan1@ufl.edu

Principal Investigator

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

Study Locations (Sites)

University of Florida Clinical and Translational Research Building
Gainesville, Florida, 32603
United States

Collaborators and Investigators

Sponsor: University of Florida

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05
Study Completion Date2026-11

Study Record Updates

Study Start Date2024-06-05
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • DMD
  • Tadalafil
  • Drug and Exercise Intervention
  • Treatment Strategy

Additional Relevant MeSH Terms

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