Aortic Stenosis in Elderly : Determinant of Progression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00338676
First received: June 19, 2006
Last updated: July 23, 2012
Last verified: June 2011

June 19, 2006
July 23, 2012
November 2006
November 2012   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00338676 on ClinicalTrials.gov Archive Site
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Aortic Stenosis in Elderly : Determinant of Progression
Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort)

Aortic stenosis (AS) is AS is caused by calcium deposits in the aortic valve. Calcification is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. The only treatment is surgery. There are evidences that AS is a regulated process with similarities to atherosclerosis but determinants of AS progression are unknown. The study aims at evaluating these determinants and more specifically the role of lipids, inflammation and platelet aggregation.

Aortic stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS prevalence increases with age and with aging of the population, AS is a major public health problem. AS is due to calcium deposits within the aortic valve. Calcium deposit is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. There is currently no effective medical therapy. Once the stenosis is severe and patients symptomatic, outcome is poor unless surgery (aortic valve replacement) is promptly performed. 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, AS progression is highly variable from one individual to another and determinants of AS progression are poorly known. Their identification is crucial if we want to develop new medical strategies. The aims of the present study are to identify the determinants of AS progression and more specifically to evaluate the role of lipids, inflammation and platelet aggregation.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples

Probability Sample

Patients diagnosed with an at least mild aortic stenosis with no indication for surgery

  • Aortic Stenosis
  • Elderly Gravida
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 70 years
  • AS with mean transmitral gradient > 10 mm Hg and aortic valve area < 2 cm2
  • No surgical indication

Exclusion Criteria:

  • Rheumatic or congenital AS
  • Associated valvular disease grade ≥ 2/4
  • Indication for surgery (severe AS (aortic valve area < 1 cm2 or < 0.6 cm2/m2 of body surface area and symptoms or congestive heart failure or left ventricular ejection fraction < 50%)
  • Renal insufficiency (creatinine clearance < 30 ml /min)
  • Left ventricular outflow tract obstruction
Both
70 Years and older
No
Contact: David Messika-Zeitoun, MD 00 1 1 40 25 66 01 david.mesika-zeitoun@bch.aphp.fr
France
 
NCT00338676
AOM05003 - P051042
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: David Messika-Zeitoun, MD Assistance Publique des Hopitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2011

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