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Aortic Stenosis in Elderly : Determinant of Progression
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, May 2008
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00338676
  Purpose

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.


Condition Phase
Aortic Stenosis
Elderly
Phase IV

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort)

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

blood samples


Estimated Enrollment: 300
Study Start Date: November 2006
Estimated Study Completion Date: November 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338676

Contacts
Contact: David Messika-Zeitoun, MD 00 1 1 40 25 66 01 david.mesika-zeitoun@bch.aphp.fr

Locations
France
Hopital Bichat Recruiting
Paris, France, 75018
Contact: David Messika-Zeitoun, MD     00 1 40 25 66 01     david.messika-zeitoun@bch.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: David Messika-Zeitoun, MD Assistance Publique des Hopitaux de Paris
  More Information

Responsible Party: Department Clinical Research of Developpement ( Christophe AUCAN )
Study ID Numbers: AOM05003 - P051042
Study First Received: June 19, 2006
Last Updated: May 26, 2008
ClinicalTrials.gov Identifier: NCT00338676  
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Aortic stenosis
Elderly

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Heart Diseases
Disease Progression
Constriction, Pathologic
Aortic valve stenosis
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on January 14, 2009