Marfan syndrome MedDRA version: 8.1 Level: LLT Classification code 10026829 Term: Marfan's syndrome
Conditions
Interventions
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.
Sponsors
University Hospital Gent
Eligibility
Sex/Gender
All
Inclusion 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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;Primary end point(s): Rate of change in aortic root (sinuses of Valsalva) BSA-adjusted Z-score | — |
Countries
Belgium
Outcome results
None listed