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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651235

Acronym

MFS

Enrollment

Registered

2008-04-02

Start date

2007-02-28

Completion date

2011-06-30

Last updated

2010-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marfan Syndrome

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.

Interventions

DRUGLosartan 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.

DRUGAtenolol or Propranolol

The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Echocardiograms	4 months

Countries

Taiwan

Contacts

Primary ContactHsin-Hui Chiou

eliachiou@yahoo.com.tw886-2-2312-3456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026