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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01361087
First Posted: May 26, 2011
Last Update Posted: February 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
May 25, 2011
May 26, 2011
February 5, 2016
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 ]
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 ]
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
Not Provided
Not Provided
 
Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With Marfan Syndrome
Circulating Transforming Growth Factor Beta (TGF-β) in Individuals With
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.
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.
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Marfan Syndrome
Other: Blood draw
This study includes one blood draw to measure circulating blood levels of TGF-B.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
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.
Sexes Eligible for Study: All
6 Months to 24 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01361087
IRB # 2011-14507
No
Not Provided
Plan to Share IPD: Undecided
Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Johns Hopkins University
Not Provided
Ann & Robert H Lurie Children's Hospital of Chicago
February 2016

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