Overview

This trial is active, not recruiting.

Conditions aortic stenosis, elderly gravida
Phase phase 4
Sponsor Assistance Publique - Hôpitaux de Paris
Start date November 2006
End date November 2017
Trial size 273 participants
Trial identifier NCT00338676, AOM05003 - P051042

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Progression of aortic stenosis
time frame: 2006 - 2017

Secondary Outcomes

Measure
AS related events
time frame: 2006 - 2017

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

Official title Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort)
Principal investigator David Messika-Zeitoun, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.