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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 11 April 2016
Main ID:  EUCTR2006-003991-37-BE
Date of registration: 06/12/2006
Prospective Registration: Yes
Primary sponsor: University Hospital Gent
Public title: Trial of beta blocker therapy (atenolol) vs. angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome - Marfan Trial
Scientific title: Trial of beta blocker therapy (atenolol) vs. angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome - Marfan Trial
Date of first enrolment: 13/12/2006
Target sample size: 600
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003991-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Belgium
Contacts
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Key inclusion & exclusion criteria
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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Marfan syndrome
MedDRA version: 8.1 Level: LLT Classification code 10026829 Term: Marfan's syndrome
Intervention(s)

Product Name: losartan
Pharmaceutical Form: Tablet
INN or Proposed INN: Losartan potassium
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12.5-

Product Name: losartan
Pharmaceutical Form: Tablet
INN or Proposed INN: Losartan potassium
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: losartan
Pharmaceutical Form: Tablet
INN or Proposed INN: Losartan potassium
CAS Number: 124750998
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Atenolol
Pharmaceutical Form: Tablet
INN or Proposed INN: Atenolol
CAS Number: 29122687
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: Atenolol
Pharmaceutical Form: Tablet
INN or Proposed INN: Atenolol
CAS Number: 29122687
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: Atenolol
Pharmaceutical Form: Tablet
INN or Proposed INN: Atenolol
CAS Number: 29122687
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on the rates of aortic growth and progression of aortic regurgitation.
Primary end point(s): Rate of change in aortic root (sinuses of Valsalva) BSA-adjusted Z-score
Secondary Objective: - To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on the incidence of the following cardiovascular events: aortic dissection, aortic root surgery, and death
- To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on the progression of mitral regurgitation
- To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on left vertricular size and function
- To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on echocardiographically-derived measures of central aortic stiffness
- To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on skeletal and somatic growth
- To compare the effect of beta blockers therapy to that of angiotension II receptor blocker therapy on the incidence of reported adverse drug reactions
Secondary Outcome(s)
Secondary ID(s)
AGO/2006/009
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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