Aortic Stenosis Clinical Trial
Official title:
Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort)
Verified date | February 2016 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 273 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Bichat | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression of aortic stenosis | 2006 - 2017 | ||
Secondary | AS related events | 2006 - 2017 |
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