Aortic Stenosis in Elderly : Determinant of Progression

• Conditions: Elderly Gravida; Aortic Stenosis

• Registration Number: NCT00338676
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2006-06-19
• Study First Submitted QC: 2006-06-19
• Study First Posted: 2006-06-20
• Study Start: 2006-11
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-01
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of aortic stenosis	2006 - 2017

Secondary Outcome Measures

Name	Time	Method
AS related events	2006 - 2017

Trial Locations

Locations (1)

Hopital Bichat; 🇫🇷 Paris, France