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

Phase 2

• Conditions: Marfan Syndrome
• Interventions: Drug: Losartan and Atenolol or Propranolol; Drug: Atenolol or Propranolol

• Registration Number: NCT00651235
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-03-03
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09
• Primary Completion: 2011-02
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B	Losartan and Atenolol or Propranolol	In 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
A	Atenolol or Propranolol	The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.

Primary Outcome Measures

Name	Time	Method
Echocardiograms	4 months

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan