| Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. | |
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MedLine Citation:
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PMID: 20619242 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Recent studies have demonstrated that blockade of the angiotensin II type 1 receptor with losartan decreases aortic damage in an animal model of Marfan syndrome (a KI mouse model with a pathogenic mutation in the gene coding for fibrillin-1). AIMS: To demonstrate a beneficial effect of losartan on aortic dilatation when added to optimal therapy in patients with Marfan syndrome. METHODS: This is a multicentre, randomized, placebo-controlled, double-blind, clinical trial with a 2-year inclusion period and a 3-year follow-up period. Aortic root diameter will be measured using two-dimensional echocardiography. Secondary endpoints will include incidence of aortic dissection, aortic root surgery, death, quality of life, tolerance and compliance with treatments. We aim to enroll a total of 300 patients aged > or =10 years who fulfil the Ghent criteria for Marfan syndrome. Analyses will be based on intention to treat. CONCLUSION: The results of this clinical trial could lead to profound modification of the management of aortic risk and complications in patients with Marfan syndrome and possibly in patients with thoracic aortic aneurysms of other aetiologies. |
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Authors:
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Delphine Detaint; Philippe Aegerter; Florence Tubach; Isabelle Hoffman; Henri Plauchu; Yves Dulac; Laurence Olivier Faivre; Marie-Ange Delrue; Patrick Collignon; Sylvie Odent; Maria Tchitchinadze; Catherine Bouffard; Florence Arnoult; Mathieu Gautier; Catherine Boileau; Guillaume Jondeau |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-07-01 |
Journal Detail:
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Title: Archives of cardiovascular diseases Volume: 103 ISSN: 1875-2128 ISO Abbreviation: Arch Cardiovasc Dis Publication Date: 2010 May |
Date Detail:
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Created Date: 2010-07-12 Completed Date: 2010-10-15 Revised Date: 2011-04-25 |
Medline Journal Info:
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Nlm Unique ID: 101465655 Medline TA: Arch Cardiovasc Dis Country: Netherlands |
Other Details:
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Languages: eng Pagination: 317-25 Citation Subset: IM |
Copyright Information:
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2010 Elsevier Masson SAS. All rights reserved. |
Affiliation:
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Centre de référence pour le syndrome de Marfan et apparentés, hôpital Bichat, Paris, France. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00763893 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Angiotensin II Type 1 Receptor Blockers
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therapeutic use* Animals Aortic Aneurysm / etiology, prevention & control*, ultrasonography Disease Models, Animal Double-Blind Method France Humans Losartan / therapeutic use* Marfan Syndrome / complications, drug therapy*, ultrasonography Mice Placebo Effect Research Design* Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Angiotensin II Type 1 Receptor Blockers; 114798-26-4/Losartan |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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