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Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome.
Arch Cardiovasc Dis. 2010 May; 103(5):317-25.AC

Abstract

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.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Detaint D
Centre de référence pour le syndrome de Marfan et apparentés, hôpital Bichat, Paris, France.
Aegerter P
No affiliation info available
Tubach F
No affiliation info available
Hoffman I
No affiliation info available
Plauchu H
No affiliation info available
Dulac Y
No affiliation info available
Faivre LO
No affiliation info available
Delrue MA
No affiliation info available
Collignon P
No affiliation info available
Odent S
No affiliation info available
Tchitchinadze M
No affiliation info available
Bouffard C
No affiliation info available
Arnoult F
No affiliation info available
Gautier M
No affiliation info available
Boileau C
No affiliation info available
Jondeau G
No affiliation info available

MeSH

Angiotensin II Type 1 Receptor BlockersAnimalsAortic AneurysmDisease Models, AnimalDouble-Blind MethodFranceHumansLosartanMarfan SyndromeMicePlacebo EffectResearch DesignTreatment OutcomeUltrasonography

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20619242

Clinical Trial Links

Clinical trial which this article describes

Citation

Detaint, Delphine, et al. "Rationale and Design of a Randomized Clinical Trial (Marfan Sartan) of Angiotensin II Receptor Blocker Therapy Versus Placebo in Individuals With Marfan Syndrome." Archives of Cardiovascular Diseases, vol. 103, no. 5, 2010, pp. 317-25.
Detaint D, Aegerter P, Tubach F, et al. Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. Arch Cardiovasc Dis. 2010;103(5):317-25.
Detaint, D., Aegerter, P., Tubach, F., Hoffman, I., Plauchu, H., Dulac, Y., Faivre, L. O., Delrue, M. A., Collignon, P., Odent, S., Tchitchinadze, M., Bouffard, C., Arnoult, F., Gautier, M., Boileau, C., & Jondeau, G. (2010). Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. Archives of Cardiovascular Diseases, 103(5), 317-25. https://doi.org/10.1016/j.acvd.2010.04.008
Detaint D, et al. Rationale and Design of a Randomized Clinical Trial (Marfan Sartan) of Angiotensin II Receptor Blocker Therapy Versus Placebo in Individuals With Marfan Syndrome. Arch Cardiovasc Dis. 2010;103(5):317-25. PubMed PMID: 20619242.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rationale and design of a randomized clinical trial (Marfan Sartan) of angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. AU - Detaint,Delphine, AU - Aegerter,Philippe, AU - Tubach,Florence, AU - Hoffman,Isabelle, AU - Plauchu,Henri, AU - Dulac,Yves, AU - Faivre,Laurence Olivier, AU - Delrue,Marie-Ange, AU - Collignon,Patrick, AU - Odent,Sylvie, AU - Tchitchinadze,Maria, AU - Bouffard,Catherine, AU - Arnoult,Florence, AU - Gautier,Mathieu, AU - Boileau,Catherine, AU - Jondeau,Guillaume, Y1 - 2010/07/01/ PY - 2010/02/25/received PY - 2010/04/23/revised PY - 2010/04/30/accepted PY - 2010/7/13/entrez PY - 2010/7/14/pubmed PY - 2010/10/16/medline SP - 317 EP - 25 JF - Archives of cardiovascular diseases JO - Arch Cardiovasc Dis VL - 103 IS - 5 N2 - 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. SN - 1875-2128 UR - https://www.unboundmedicine.com/medline/citation/20619242/Rationale_and_design_of_a_randomized_clinical_trial__Marfan_Sartan__of_angiotensin_II_receptor_blocker_therapy_versus_placebo_in_individuals_with_Marfan_syndrome_ DB - PRIME DP - Unbound Medicine ER -