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NCT Number: NCT06713889

Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI

Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient.

Patients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology).

Outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present.

Patients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI).

The main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon - Hôpital Croix Rousse, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients >=18 years of age
  • Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC).
  • No opposition.

Exclusion criteria

  • Conjunctive heart disease (e.g. amyloidosis).
  • Presence of a contraindication to TAVI.
  • Impossibility of giving the subject informed information.
  • Privation of civil rights (curatorship, tutorship, protection of justice).

Treatment and study plan

Biocollection

Biological

At each sampling time, 2 dry tubes of 4 ml, 1 EDTA tube of 4 ml, and 1 heparinised tube of 4 ml, i.e. a total of 16 ml per sampling time.

Group A patients will be sampled at inclusion (or before the TAVI procedure), during and after the TAVI procedure, at 1 month follow-up and at 1 year follow-up, for a total of 120 ml. Patients in groups B and C will be sampled at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up, for a total of 80 ml.

Quality of life questionnaires

Behavioral

EQ-5D-5L and HAD questionnaire at inclusion, 1 month follow-up, 1 year follow-up and 2 years follow-up

Primary outcomes

  1. Comparing biomarkers

    Time frame: At V0 (inclusion), V4 (1-month follow up) and V5 (1-year follow up).

    The primary endpoint is the level of biomarkers of inflammation and fibrosis in the 3 groups of patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmad HAYEK, MD

CONTACT

[email protected]

4 72 35 72 80 ext. +33

Yvonne VARILLON

CONTACT

[email protected]

4 72 35 69 64 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: Bio-TAVI

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Dec 3, 2024
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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