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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Marfan Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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B

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

Group Type EXPERIMENTAL

Losartan and Atenolol or Propranolol

Intervention Type DRUG

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.

A

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

Group Type ACTIVE_COMPARATOR

Atenolol or Propranolol

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Atenolol or Propranolol

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

Intervention Type DRUG

Other Intervention Names

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Cozaar and Tenormin or Inderal Tenormin or Inderal

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No