A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome

Marfan Syndrome Clinical Trial

— MFS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00651235
• Other study ID #: 200610030M
• Status: Recruiting
• Phase: Phase 2
• First received: March 3, 2008
• Last updated: June 8, 2010
• Start date: February 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: Hsin-Hui Chiou
• Phone: 886-2-2312-3456
• Email: eliachiou[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Marfan Syndrome
• Syndrome

Intervention

Drug:
• Losartan and Atenolol or Propranolol
50 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.
• Atenolol or Propranolol
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiograms		4 months	No