Aortic Stenosis in Elderly : Determinant of Progression

Brief Title

Aortic Stenosis in Elderly : Determinant of Progression

Official Title

Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort)

Brief Summary

      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.

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.

Study Type

Observational

Primary Outcome

Progression of aortic stenosis

Secondary Outcome

 AS related events

Condition

Aortic Stenosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

Start Date

November 2006

Completion Date

September 2017

Primary Completion Date

September 2017

Eligibility 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

Gender

All

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David Messika-Zeitoun, MD, ,

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT00338676

Organization ID

AOM05003 - P051042

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

David Messika-Zeitoun, MD, Principal Investigator, Assistance Publique des Hopitaux de Paris

Verification Date

February 2016