Valvulopathy
Conditions
Keywords
Microbiota
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.
Interventions
BIOLOGICALCollection of biological samples
Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactJean PORTERIE, MD
Outcome results
None listed