Marfan Syndrome | A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
Marfan Syndrome research study
What is the primary objective of this study?
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.
Who is eligible to participate?
Inclusion criteria - Marfan syndrome with recognized aortic root dilation - Patients must be older than one year of age - Beta-blocker treatment at least three months - Must sign an informed consent form Exclusion criteria - Prior to aortic root surgery - Aortic root dimension more than 5.5cm - Aortic surgery within 6 months - Diabetes mellitus or liver and renal dysfunction or asthma - Pregnancy - Intolerance to Losartan therapy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Losartan and Atenolol or Propranolol50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children. Losartan is 100 mg/day for adult and 50 mg/day for children.
Drug:Atenolol or PropranololThe maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
BIn combination therapy,the maximal dose of Losartan is 100 mg/day for adult and 50 mg/day for children. 50 mg of Atenolol once daily, 20 mg of Propranolol twice daily for adult and 1 mg/Kg/day for children
AThe maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Start Date: February 2007
Completed Date: June 2011
Phase: Phase 2
Primary Outcome: Echocardiograms
Study sponsors, principal investigator, and references
Principal Investigator: Mei-Hwan Wu
Lead Sponsor: National Taiwan University Hospital