Valvular Microbiota and Valvulopathy

Not Applicable

Recruiting

• Conditions: Valvulopathy
• Interventions: Biological: Collection of biological samples

• Registration Number: NCT06407128
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-09
• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Last Update Submitted: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Posted: 2024-05-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Collection of biological samples	Collection of biological samples	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.

Primary Outcome Measures

Name	Time	Method
Detection of blood and tissue microbiota	12 months	Detection of a blood microbiota in the pre-operative sample and a valve microbiota in the operating part.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France