Aortic Stenosis in Elderly : Determinant of Progression
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort) |
blood samples
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients diagnosed with an at least mild aortic stenosis with no indication for surgery
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
Contacts and Locations| Contact: David Messika-Zeitoun, MD | 00 1 1 40 25 66 01 | david.mesika-zeitoun@bch.aphp.fr |
| France | |
| Hopital Bichat | Recruiting |
| Paris, France, 75018 | |
| Contact: David Messika-Zeitoun, MD 00 1 40 25 66 01 david.messika-zeitoun@bch.aphp.fr | |
| Principal Investigator: | David Messika-Zeitoun, MD | Assistance Publique des Hopitaux de Paris |
More Information
No publications provided by Assistance Publique - Hôpitaux de Paris
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00338676 History of Changes |
| Other Study ID Numbers: | AOM05003 - P051042 |
| Study First Received: | June 19, 2006 |
| Last Updated: | July 23, 2012 |
| Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Aortic stenosis Elderly |
Additional relevant MeSH terms:
|
Aortic Valve Stenosis Constriction, Pathologic Heart Valve Diseases Heart Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013