Comparison of Two Medications Aimed at Slowing Aortic Root Enlargement in Individuals With Marfan Syndrome

Completed · Phase 3

Conditions studied: Marfan Syndrome

In brief

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 effectiveness of two medications, losartan and atenolol, at slowing aortic root enlargement in individuals with Marfan syndrome.

Key facts

Study ID

NCT00429364

Run by

Carelon Research

People needed

608

Starts

2007-01-01

Expected to finish

2014-02-01

Last updated by the study team

2025-03-07

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Lucile Packard Children's Hospital — Palo Alto, California, United States
• Rady Children's Hospital / UCSD — San Diego, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Children's Hospital of Minnesota - St. Paul — Saint Paul, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia College of Physicians and Surgeons — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Ghent University Hospital — Ghent, Gent, Belgium

Full record on ClinicalTrials.gov

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