NCT05809323 Marfan Syndrome Moderate Exercise Trial II
| NCT ID | NCT05809323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baylor College of Medicine |
| Condition | Marfan Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2025-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2023-09-01 with a primary completion date of 2025-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Given limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities. The lack of exercise and deconditioning have detrimental effects including increasing weakness, joint pain, decreased endurance, and depressive symptoms. Given the significant paucity of data currently existing on the effects of exercise in humans with MFS, and the recent, optimistic findings in rodent models, this pilot trial was established to assess the effects of moderated dynamic exercise in adolescents and young adults with MFS.
Eligibility Criteria
Inclusion Criteria: * Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis) * Age 10-25 years at enrollment Exclusion Criteria: 1. History of aortic surgery 2. History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality. 3. Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria) 4. Condition limiting the ability to perform moderate exercise. 5. Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures. 6. Aortic dilation meeting threshold for prophylactic aortic surgical intervention (\>/= 4.5 cm in diameter)
Contact & Investigator
Shaine A Morris, MD, MPH
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT05809323 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 25 Years, studying Marfan Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05809323 currently recruiting?
Yes, NCT05809323 is actively recruiting participants. Contact the research team at shainem@bcm.edu for enrollment information.
Where is the NCT05809323 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT05809323 clinical trial?
NCT05809323 is sponsored by Baylor College of Medicine. The principal investigator is Shaine A Morris, MD, MPH at Baylor College of Medicine. The trial plans to enroll 50 participants.