Genetic of Aortic Valve Stenosis - Clinical and Therapeutic Implications

NCT ID: NCT00647088

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2017-12-31

Brief Summary

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Pathophysiology of Aortic Valve Stenosis remains poorly known. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design.

Detailed Description

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Aortic valve stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, pathophysiology of AS remains poorly understood and preliminary data suggest that genetic factors may be involved. The aim of the present study is to identify genetic factors involved in this disease using a case control trial design (1000 patients with AS and 1500 controls with no evidence of valve disease). For all patients and controls, blood samples including DNA and echocardiography will be performed.

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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aortic stenosis

various age and disease severity

No interventions assigned to this group

Controls

Controls free of valvular disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \>=18 years
* Pure isolated degenerative aortic valve stenosis


\- Age \>=18 years

Exclusion Criteria

* Rheumatic, congenital or post-radiation aortic stenosis
* Severe renal insufficiency (clearance \< 30 ml/min)
* Aortic insufficiency \> or = grade 2/4
* Other valve disease \> or = grade 2/4

Controls


* Known first degree relative with aortic valve stenosis
* Severe renal insufficiency (clearance \< 30 ml/min)
* Any valve disease \> or = grade 2/4
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Messika-Zeitoun, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Assistance Publique - Hôpitaux de Paris, Bichat Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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David MESSIKA-ZEITOUN, MD

Role: primary

01 40 25 66 01 ext. 00 33

References

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Perrot N, Theriault S, Dina C, Chen HY, Boekholdt SM, Rigade S, Despres AA, Poulin A, Capoulade R, Le Tourneau T, Messika-Zeitoun D, Trottier M, Tessier M, Guimond J, Nadeau M, Engert JC, Khaw KT, Wareham NJ, Dweck MR, Mathieu P, Pibarot P, Schott JJ, Thanassoulis G, Clavel MA, Bosse Y, Arsenault BJ. Genetic Variation in LPA, Calcific Aortic Valve Stenosis in Patients Undergoing Cardiac Surgery, and Familial Risk of Aortic Valve Microcalcification. JAMA Cardiol. 2019 Jul 1;4(7):620-627. doi: 10.1001/jamacardio.2019.1581.

Reference Type DERIVED
PMID: 31141105 (View on PubMed)

Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuellar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.

Reference Type DERIVED
PMID: 29555836 (View on PubMed)

Kubota N, David Messika-Zeitoun D. P650Influence of fetunin-a level on progression of calcific aortic valve stenosis The COFRASA - GENERAC Study. Eur Heart J Cardiovasc Imaging. 2016 Dec 1;17(suppl_2):ii130-ii136. doi: 10.1093/ehjci/jew250.001.

Reference Type DERIVED
PMID: 28415102 (View on PubMed)

Arangalage D, Nguyen V, Robert T, Melissopoulou M, Mathieu T, Estellat C, Codogno I, Huart V, Duval X, Cimadevilla C, Vahanian A, Dehoux M, Messika-Zeitoun D. Determinants and prognostic value of Galectin-3 in patients with aortic valve stenosis. Heart. 2016 Jun 1;102(11):862-8. doi: 10.1136/heartjnl-2015-308873. Epub 2016 Feb 19.

Reference Type DERIVED
PMID: 26896466 (View on PubMed)

Guauque-Olarte S, Messika-Zeitoun D, Droit A, Lamontagne M, Tremblay-Marchand J, Lavoie-Charland E, Gaudreault N, Arsenault BJ, Dube MP, Tardif JC, Body SC, Seidman JG, Boileau C, Mathieu P, Pibarot P, Bosse Y. Calcium Signaling Pathway Genes RUNX2 and CACNA1C Are Associated With Calcific Aortic Valve Disease. Circ Cardiovasc Genet. 2015 Dec;8(6):812-22. doi: 10.1161/CIRCGENETICS.115.001145. Epub 2015 Nov 9.

Reference Type DERIVED
PMID: 26553695 (View on PubMed)

Chin CW, Messika-Zeitoun D, Shah AS, Lefevre G, Bailleul S, Yeung EN, Koo M, Mirsadraee S, Mathieu T, Semple SI, Mills NL, Vahanian A, Newby DE, Dweck MR. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis. Eur Heart J. 2016 Feb 21;37(8):713-23. doi: 10.1093/eurheartj/ehv525. Epub 2015 Oct 21.

Reference Type DERIVED
PMID: 26491110 (View on PubMed)

Dreyfus J, Durand-Viel G, Raffoul R, Alkhoder S, Hvass U, Radu C, Al-Attar N, Ghodbhane W, Attias D, Nataf P, Vahanian A, Messika-Zeitoun D. Comparison of 2-Dimensional, 3-Dimensional, and Surgical Measurements of the Tricuspid Annulus Size: Clinical Implications. Circ Cardiovasc Imaging. 2015 Jul;8(7):e003241. doi: 10.1161/CIRCIMAGING.114.003241.

Reference Type DERIVED
PMID: 26156015 (View on PubMed)

Nguyen V, Cimadevilla C, Estellat C, Codogno I, Huart V, Benessiano J, Duval X, Pibarot P, Clavel MA, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Haemodynamic and anatomic progression of aortic stenosis. Heart. 2015 Jun;101(12):943-7. doi: 10.1136/heartjnl-2014-307154. Epub 2015 Feb 5.

Reference Type DERIVED
PMID: 25655063 (View on PubMed)

Kochtebane N, Passefort S, Choqueux C, Ainoun F, Achour L, Michel JB, Back M, Jacob MP. Release of leukotriene B4, transforming growth factor-beta1 and microparticles in relation to aortic valve calcification. J Heart Valve Dis. 2013 Nov;22(6):782-8.

Reference Type DERIVED
PMID: 24597398 (View on PubMed)

Cimadevilla C, Cueff C, Hekimian G, Dehoux M, Lepage L, Iung B, Duval X, Huart V, Tubach F, Vahanian A, Messika-Zeitoun D. Prognostic value of B-type natriuretic peptide in elderly patients with aortic valve stenosis: the COFRASA-GENERAC study. Heart. 2013 Apr;99(7):461-7. doi: 10.1136/heartjnl-2012-303284. Epub 2013 Jan 24.

Reference Type DERIVED
PMID: 23349346 (View on PubMed)

Other Identifiers

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P070141

Identifier Type: -

Identifier Source: org_study_id

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