CompletedPhase 3

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

United States, Belgium, Canada608 participantsStarted 2007-01

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

Who can participate

Age range

6 Months – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Annual Rate of Change in Aortic Root (Sinuses of Valsalva) Body-surface-area-adjusted Z-score

Timeframe: Up to 3 years following randomization.

Trial details

NCT IDNCT00429364

SponsorCarelon Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

Results submitted2015-02-25

View on ClinicalTrials.gov More Marfan Syndrome trials