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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
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Marfan Syndrome

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 3, 2008
Last Updated
June 8, 2010
Sponsor
National Taiwan University Hospital
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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

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

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