Status:
COMPLETED
Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
FDA Office of Orphan Products Development
Conditions:
Marfan Syndrome
Eligibility:
All Genders
6-25 years
Phase:
PHASE3
Brief Summary
Marfan syndrome is a hereditary connective tissue disorder. Many individuals with this condition die because of the associated heart and blood vessel abnormalities. This study will compare the effecti...
Detailed Description
Marfan syndrome is an inheritable disorder that affects the body's connective tissue. An abnormal protein results in connective tissue that is weaker than normal. Because connective tissue is found th...
Eligibility Criteria
Inclusion
- Diagnosis of Marfan syndrome, according to Ghent criteria (more information can be found in Appendix D of the protocol)
- Aortic root Z-score greater than 3.0
Exclusion
- Prior aortic surgery
- Aortic root dimension at the sinuses of Valsalva greater than 5 cm
- Planned aortic surgery within 6 months of study entry
- Aortic dissection
- Shprintzen-Goldberg syndrome
- Loeys-Dietz syndrome
- Therapeutic (i.e., for arrhythmia, ventricular dysfunction, or valve regurgitation) rather than prophylactic use of angiotensin-converting enzyme (ACE) inhibitor, beta-blocker, or calcium channel blocker
- History of angioedema while taking an ACE inhibitor or beta-blocker
- Intolerance to losartan or other angiotensin II receptor blocker (ARB) that resulted in termination of therapy
- Intolerance to atenolol or other beta-blocker that resulted in termination of therapy
- Kidney dysfunction (i.e., creatinine greater than the upper limit of age-related normal values)
- Asthma of sufficient severity to prohibit the use of a beta-blocker
- Chronic use of steroids and/or beta-adrenergic agents with exacerbations of asthma that are frequent (averaging three or more per year) or severe (requiring hospitalization)
- Diabetes mellitus
- Pregnant or planning to become pregnant within 36 months of study entry
- Inability to complete study procedures, including history of poor acoustic windows (i.e., inability to obtain accurate measurement of aortic root)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
608 Patients enrolled
Trial Details
Trial ID
NCT00429364
Start Date
January 1 2007
End Date
February 1 2014
Last Update
March 7 2025
Active Locations (26)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
3
Rady Children's Hospital / UCSD
San Diego, California, United States, 92123
4
Stanford University School of Medicine
Stanford, California, United States, 94305