The Ghent Marfan Trial-A randomized, double-blind placebo controlled trial with losartan in Marfan patients treated with β-blockers
International Journal of Cardiology, 06/13/2012
Moberg K et al. – This trial will study new therapeutic strategies for the prevention of serious cardiovascular complications in marfan syndrome (MFS).Methods
- Authors are conducting a prospective randomized placebo controlled double blind phase III study aiming to include 174 MFS patients (age ≥10years and z–score ≥2).
- Patients already taking β–blockers are randomized for weight–adjusted treatment with losartan versus placebo.
- The primary endpoint is decrease in aortic root growth rate.
- Secondary endpoints are aortic dissection/surgery, progression of aortic/mitral regurgitation, arterial stiffness, left ventricular systolic/diastolic function, quality of life and genetic modifiers.
- Echocardiography, vascular echo–Doppler and quality of life assessment will be performed at baseline and at 6–monthly follow–ups for 3years.
- MRI evaluation will be performed at baseline and at the end of the trial.
- The uniqueness in this trial is that the additive effect of losartan and β–blocker will be evaluated in a large spectrum of disease severity.
- A combination of ultrasound and MRI will allow detailed evaluation of anatomic and functional properties of the aorta and left ventricle.