Clinical trial
Valvular Microbiota and Valvulopathy
Name
RC31/22/0108
Description
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.
Trial arms
Trial start
2024-01-09
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Recruiting
Treatment
Collection of biological samples
Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)
Arms:
Collection of biological samples
Size
100
Primary endpoint
Detection of blood and tissue microbiota
12 months
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-05-09
1 organization
1 product
1 indication
Organization
University Hospital of ToulouseIndication
Valvulopathy