Trial of beta blocker therapy (atenolol) vs. angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome - Marfan Trial

• Conditions: Marfan syndrome; MedDRA version: 8.1Level: LLTClassification code 10026829Term: Marfan's syndrome

• Registration Number: EUCTR2006-003991-37-BE
• Lead Sponsor: niversity Hospital Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-06
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

To be eligible for this trial the subjects must meet all of the following inclusion criteria at the time of enrollment:
1) Diagnosis of MFS according to Ghent criteria
2) Age 6 months to 25 years.
3) Aortic root Z-score > 3.0.
4) Informed consent of parent(s) or legal guardian; informed consent or assent of subject as applicable.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible for this trial, the subjects must meet none of the following exclusion criteria at the time of enrollment:
1) Prior aortic surgery.
2) Aortic root dimension at the sinuses of Valsalva > 5 cm.
3) Planned aortic surgery within 6 months of enrollment.
4) Aortic dissection.
5) Shprintzen-Goldberg syndrome
6) Loeys-Dietz syndrome
7) Therapeutic (e.g. for arrhythmia, ventricular dysfunction or valve regurgitation) rather than prophylactic use of ACE inhibitor, BB, or calcium channel blocker.
8) History of angioedema while taking an ACE inhibitor or BB.
9) Intolerance to losartan or other ARB that resulted in termination of therapy.
10) Intolerance to atenolol or other BB that resulted in termination of therapy.
11) Renal dysfunction (Creatinine >upper limit of age-related normal values).
12) Asthma of sufficient severity to preclude the use of a BB: 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).
13) Diabetes mellitus.
14) Pregnancy or planned pregnancy within 36 months of enrollment.
15) Inability to complete study procedures including history of poor acoustic windows (inability to obtain accurate measurement of aortic root).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified