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
273
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