Aortic Stenosis in Elderly : Determinant of Progression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00338676
First received: June 19, 2006
Last updated: July 23, 2012
Last verified: June 2011
  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.


Condition Phase
Aortic Stenosis
Elderly Gravida
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Biospecimen Retention:   Samples With DNA

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)
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients diagnosed with an at least mild aortic stenosis with no indication for surgery

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338676

Contacts
Contact: David Messika-Zeitoun, MD 00 1 1 40 25 66 01 david.mesika-zeitoun@bch.aphp.fr

Locations
France
Hopital Bichat Recruiting
Paris, France, 75018
Contact: David Messika-Zeitoun, MD    00 1 40 25 66 01    david.messika-zeitoun@bch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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 July 23, 2014