Valvular Microbiota and Valvulopathy

Valvulopathy Clinical Trial

— MICROVALV  

Official title:

Valvular Microbiota and Valvulopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407128
• Other study ID #: RC31/22/0108
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Toulouse
• Contact: Jean PORTERIE, MD
• Phone: 5 61 32 24 12
• Email: porterie.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valvulopathy

Intervention

Biological:
• Collection of biological samples
Collection of biological samples (blood sample + valve tissue sample + saliva, periodontal and feces sample)

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of blood and tissue microbiota	Detection of a blood microbiota in the pre-operative sample and a valve microbiota in the operating part.	12 months