Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With Marfan Syndrome

This study has been withdrawn prior to enrollment.
(No outside recruitment of subjects from Main Atenolol VS Losartan NIH study)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01361087
First received: May 25, 2011
Last updated: June 30, 2011
Last verified: May 2011

May 25, 2011
June 30, 2011
April 2011
December 2014   (final data collection date for primary outcome measure)
To determine if circulating levels of TGF-β correlate with treatment arms: Atenolol vs. Losartan. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01361087 on ClinicalTrials.gov Archive Site
To determine if circulating levels of TGF-β correlate with clinical outcomes within a treatment group or independent treatment groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
These clinical outcomes may be a change in aortic root Z-score, final aortic root dimension, final aortic root Z-score and other clinical outcomes in the main Marfan trial.
Same as current
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Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With Marfan Syndrome
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Transforming Growth Factor Beta (TGF-β) is a protein that controls proliferation, cellular differentiation, and other functions in most cells. TGF-β levels play a major role in the pathogenesis of Marfan syndrome, a disease characterized by disproportionate height, long extremities, lens dislocation in the eyes and heart complications such as mitral valve prolapse and aortic enlargement increasing the likelihood of aortic dissection. While the underlying defect in Marfan syndrome is faulty synthesis of the glycoprotein fibrillin I, normally an important component of elastic fibers it has been shown that the Marfan syndrome phenotype can be relieved by addition of a TGF-β antagonist in affected mice. This suggest that while the symptoms of Marfan syndrome may seem consistent with a connective tissue disorder, the mechanism is more likely related to reduced sequestration of TGF-β by fibrillin.

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Interventional
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Marfan Syndrome
Other: Blood draw
This study includes one blood draw to measure circulating blood levels of TGF-B.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individual with Marfan syndrome consented in to the Main Atenolol Vs. Losartan NIH study.

Exclusion Criteria:

  • Subjects in the main PHN Marfan trial who have not achieved the maintenance drug dosing or who have stopped taking study drug.
Both
6 Months to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01361087
IRB # 2011-14507
Yes
Luciana T. Young M.D., Childrens Memorial Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Johns Hopkins University
Not Provided
Ann & Robert H Lurie Children's Hospital of Chicago
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP