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Aortic StenosisNCT00338676

Aortic Stenosis in Elderly : Determinant of Progression

An observational study of Aortic Stenosis and Elderly Gravida, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Aortic Stenosis, Elderly Gravida
How many people
273 participants
Where
1 siteFrance
Study dates
Nov 2006to Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • Age ≥ 70 years
  • AS with mean transmitral gradient > 10 mm Hg and aortic valve area < 2 cm2
  • No surgical indication

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hopital Bichat

    Paris, 75018

Other trials in France

About this study

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

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.

Read the 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.

Keywords
Aortic stenosis, Elderly
Medical subject headings
Aortic Valve Stenosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression of aortic stenosis

    Measured: 2006 - 2017

Secondary outcomes (1)

  1. AS related events

    Measured: 2006 - 2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338676
Sponsor's protocol ID
AOM05003 - P051042
Status last verified
Feb 2016
First submitted
19 Jun 2006
Last updated
1 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Dhayni K, Chabry Y, Henaut L, Avondo C, Boudot C, Ouled-Haddou H, Bigot-Corbel E, Touati G, Caus T, Messaoudi H, Bellien J, Tribouilloy C, Messika-Zeitoun D, Zibara K, Kamel S, Bennis Y. Aortic valve calcification is promoted by interleukin-8 and restricted through antagonizing CXC motif chemokine receptor 2. Cardiovasc Res. 2023 Oct 24;119(13):2355-2367. doi: 10.1093/cvr/cvad117.

    PubMed 37517061

  • Perrot N, Theriault S, Dina C, Chen HY, Boekholdt SM, Rigade S, Despres AA, Poulin A, Capoulade R, Le Tourneau T, Messika-Zeitoun D, Trottier M, Tessier M, Guimond J, Nadeau M, Engert JC, Khaw KT, Wareham NJ, Dweck MR, Mathieu P, Pibarot P, Schott JJ, Thanassoulis G, Clavel MA, Bosse Y, Arsenault BJ. Genetic Variation in LPA, Calcific Aortic Valve Stenosis in Patients Undergoing Cardiac Surgery, and Familial Risk of Aortic Valve Microcalcification. JAMA Cardiol. 2019 Jul 1;4(7):620-627. doi: 10.1001/jamacardio.2019.1581.

    PubMed 31141105

  • Pawade T, Clavel MA, Tribouilloy C, Dreyfus J, Mathieu T, Tastet L, Renard C, Gun M, Jenkins WSA, Macron L, Sechrist JW, Lacomis JM, Nguyen V, Galian Gay L, Cuellar Calabria H, Ntalas I, Cartlidge TRG, Prendergast B, Rajani R, Evangelista A, Cavalcante JL, Newby DE, Pibarot P, Messika Zeitoun D, Dweck MR. Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis. Circ Cardiovasc Imaging. 2018 Mar;11(3):e007146. doi: 10.1161/CIRCIMAGING.117.007146.

    PubMed 29555836

  • Arangalage D, Nguyen V, Robert T, Melissopoulou M, Mathieu T, Estellat C, Codogno I, Huart V, Duval X, Cimadevilla C, Vahanian A, Dehoux M, Messika-Zeitoun D. Determinants and prognostic value of Galectin-3 in patients with aortic valve stenosis. Heart. 2016 Jun 1;102(11):862-8. doi: 10.1136/heartjnl-2015-308873. Epub 2016 Feb 19.

    PubMed 26896466

  • Chin CW, Messika-Zeitoun D, Shah AS, Lefevre G, Bailleul S, Yeung EN, Koo M, Mirsadraee S, Mathieu T, Semple SI, Mills NL, Vahanian A, Newby DE, Dweck MR. A clinical risk score of myocardial fibrosis predicts adverse outcomes in aortic stenosis. Eur Heart J. 2016 Feb 21;37(8):713-23. doi: 10.1093/eurheartj/ehv525. Epub 2015 Oct 21.

    PubMed 26491110

  • Nguyen V, Cimadevilla C, Estellat C, Codogno I, Huart V, Benessiano J, Duval X, Pibarot P, Clavel MA, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Haemodynamic and anatomic progression of aortic stenosis. Heart. 2015 Jun;101(12):943-7. doi: 10.1136/heartjnl-2014-307154. Epub 2015 Feb 5.

    PubMed 25655063

  • Cimadevilla C, Cueff C, Hekimian G, Dehoux M, Lepage L, Iung B, Duval X, Huart V, Tubach F, Vahanian A, Messika-Zeitoun D. Prognostic value of B-type natriuretic peptide in elderly patients with aortic valve stenosis: the COFRASA-GENERAC study. Heart. 2013 Apr;99(7):461-7. doi: 10.1136/heartjnl-2012-303284. Epub 2013 Jan 24.

    PubMed 23349346

  • Hekimian G, Boutten A, Flamant M, Duval X, Dehoux M, Benessiano J, Huart V, Dupre T, Berjeb N, Tubach F, Iung B, Vahanian A, Messika-Zeitoun D. Progression of aortic valve stenosis is associated with bone remodelling and secondary hyperparathyroidism in elderly patients--the COFRASA study. Eur Heart J. 2013 Jul;34(25):1915-22. doi: 10.1093/eurheartj/ehs450. Epub 2013 Jan 17.

    PubMed 23329150

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis and Elderly Gravida, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression of aortic stenosis (time frame: 2006 - 2017). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00338676, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.

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