A Randomized, Open-Label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
Information source: National Taiwan University Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Marfan Syndrome
Intervention: Losartan and Atenolol or Propranolol (Drug); Atenolol or Propranolol (Drug)
Phase: Phase 2
Status: Enrolling by invitation
Sponsored by: National Taiwan University Hospital Official(s) and/or principal investigator(s):
Mei-Hwan Wu, Principal Investigator, Affiliation: National Taiwan University Hospital
Summary
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive
dilation of aortic root in patients with Marfan syndrome.
Clinical Details
Official title: A Randomized, Open-Label, Active Control Trial to Evaluate the Effect of LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
Study design: Prevention, Randomized, Open Label, Factorial Assignment, Safety/Efficacy Study
Primary outcome: Echocardiograms
Detailed description:
Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant
inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal
system. The most life-threatening complication of MFS is progressive aortic root dilation
leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1)
antagonist, is a drug already in clinical use for hypertension and type II diabetic
nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung
problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine
the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation
prevention.
Eligibility
Minimum age: 1 Year.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2007
Ending date: June 2011
Last updated: April 1, 2008
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