- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651235
A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome (MFS)
June 8, 2010 updated by: National Taiwan University Hospital
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
To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hsin-Hui Chiou
- Phone Number: 3160 886-2-2312-3456
- Email: eliachiou@yahoo.com.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
|
Active Comparator: A
The maximal dose of Atenolol or Propranolol is 150 mg/day for adult and 2 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Echocardiograms
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mei-Hwan Wu, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
March 3, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 2, 2008
Study Record Updates
Last Update Posted (Estimate)
June 9, 2010
Last Update Submitted That Met QC Criteria
June 8, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Disease
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bone Diseases
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Bone Diseases, Developmental
- Limb Deformities, Congenital
- Syndrome
- Marfan Syndrome
- Arachnodactyly
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Propranolol
- Losartan
- Atenolol
Other Study ID Numbers
- 200610030M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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