Aortic Stenosis in Elderly : Determinant of Progression

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00338676
• Other study ID #: AOM05003 - P051042
• Status: Active, not recruiting
• Phase: N/A
• First received: June 19, 2006
• Last updated: February 27, 2017
• Start date: November 2006
• Est. completion date: September 2017

Study information

• Verified date: February 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Elderly Gravida

Locations

Country	Name	City	State
France	Hopital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of aortic stenosis		2006 - 2017
Secondary	AS related events		2006 - 2017