A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome (MFS)
Primary Purpose
Marfan Syndrome
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Losartan and Atenolol or Propranolol
Atenolol or Propranolol
Sponsored by
About this trial
This is an interventional prevention trial for Marfan Syndrome
Eligibility 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
B
A
Arm 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
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Outcomes
Primary Outcome Measures
Echocardiograms
Secondary Outcome Measures
Full Information
NCT ID
NCT00651235
First Posted
March 3, 2008
Last Updated
June 8, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00651235
Brief Title
A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
Acronym
MFS
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marfan Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Experimental
Arm 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
Arm Title
A
Arm Type
Active Comparator
Arm Description
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Intervention Type
Drug
Intervention Name(s)
Losartan and Atenolol or Propranolol
Other Intervention Name(s)
Cozaar and Tenormin or Inderal
Intervention Description
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
Intervention Name(s)
Atenolol or Propranolol
Other Intervention Name(s)
Tenormin or Inderal
Intervention Description
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 mg/Kg/day for children.
Primary Outcome Measure Information:
Title
Echocardiograms
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Hui Chiou
Phone
886-2-2312-3456
Ext
3160
Email
eliachiou@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Hwan Wu
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
23321647
Citation
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.
Results Reference
derived
Learn more about this trial
A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
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