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Aortic Stenosis in Elderly : Determinant of Progression

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00338676
Enrollment
273
Registered
2006-06-20
Start date
2006-11-30
Completion date
2017-09-30
Last updated
2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Elderly Gravida

Keywords

Aortic stenosis, Elderly

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression of aortic stenosis2006 - 2017

Secondary

MeasureTime frame
AS related events2006 - 2017

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026