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

National Taiwan University

Status and phase

Unknown

Phase 2

Conditions

Marfan Syndrome

Treatments

Drug: Atenolol or Propranolol

Drug: Losartan and Atenolol or Propranolol

Study type

Interventional

Funder types

Other

Identifiers

NCT00651235

200610030M

Details and patient eligibility

About

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

Full 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.

Enrollment

44 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

44 participants in 2 patient groups

Experimental group

Description:

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

Treatment:

Drug: Losartan and Atenolol or Propranolol

Active Comparator group

Description:

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

Treatment:

Drug: Atenolol or Propranolol