A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
MFS
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
1 other identifier
interventional
44
1 country
1
Brief Summary
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 9, 2010
June 1, 2010
4 years
March 3, 2008
June 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Echocardiograms
4 months
Study Arms (2)
B
EXPERIMENTALIn 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
ACTIVE COMPARATORThe maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Interventions
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.
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
Chiu HH, Wu MH, Wang JK, Lu CW, Chiu SN, Chen CA, Lin MT, Hu FC. Losartan added to beta-blockade therapy for aortic root dilation in Marfan syndrome: a randomized, open-label pilot study. Mayo Clin Proc. 2013 Mar;88(3):271-6. doi: 10.1016/j.mayocp.2012.11.005. Epub 2013 Jan 12.
PMID: 23321647DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mei-Hwan Wu
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2008
First Posted
April 2, 2008
Study Start
February 1, 2007
Primary Completion
February 1, 2011
Study Completion
June 1, 2011
Last Updated
June 9, 2010
Record last verified: 2010-06