Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00651235
First received: March 3, 2008
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Marfan Syndrome
 Drug: Losartan and Atenolol or Propranolol
Drug: Atenolol or Propranolol
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Marfan Syndrome
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Echocardiograms [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: February 2007
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 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.

Other Name: Cozaar and Tenormin or Inderal
Active Comparator: A
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
 Drug: Atenolol or Propranolol
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Other Name: Tenormin or Inderal

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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651235

Contacts
Contact: Hsin-Hui Chiou 886-2-2312-3456 ext 3160 eliachiou@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Mei-Hwan Wu National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Mei -Hwan Wu, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00651235     History of Changes
Other Study ID Numbers: 200610030M
Study First Received: March 3, 2008
Last Updated: June 8, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Marfan Syndrome
Arachnodactyly
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
 Atenolol
Propranolol
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 16, 2013