Valvular Microbiota and Valvulopathy (MICROVALV)

Toulouse University Hospital

Status: Enrolling

Conditions: Valvulopathy

Treatments: Biological: Collection of biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT06407128

RC31/22/0108

Details and patient eligibility

About

Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011.

Having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. This study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (AVR) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. This would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Indication for surgical AVR:

  • Tight RA:

    • symptomatic (dyspnea, syncope/lipothymia, angina);
    • and/or echocardiographic criterion:

• valve surface < 1cm2 (and/or 0.6cm2/m2);

• average transvalvular gradient > 40mmHg;

• aortic jet velocity (Vmax) > 4.0m/s;

  • or low transvalvular gradient (mean gradient < 40mmHg) + left ventricular ejection fraction (LVEF) < 50% but contractile reserve;

  • and/or high calcium score on CT angiography;

    • Asymptomatic tight RA and:

  • LVEF < 50% without other cause;

  • and/or symptoms during exercise;

  • and/or low surgical risk + severity criteria: Vmax > 5.5m/s (or progression > 0.3m/s/year), NT-proBNP level > 3Xnormal, severe pulmonary arterial hypertension (pulmonary systolic pressure > 60mmHg);

    • Moderate AR + concomitant surgical indication for another heart disease;
    • Severe AI: regurgitant orifice > 30mm2, regurgitated volume > 60ml/beat,

  • symptomatic (dyspnea, syncope/lipothymia, angina);

  • and/or left ventricular dysfunction: LVEF < 50%, end-diastolic diameter > 70mm, end-systolic diameter > 50mm (or > 25mm/m2);

  • and/or concomitant surgical indication for another heart disease.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Collection of biological samples

Experimental group

Description:

The samples (1ml blood sample + approximately 90-100mg of valve tissue + saliva, periodontal and feces samples) will be collected at the time of T0 inclusion in the cardiovascular surgery department.

Treatment:

Biological: Collection of biological samples