Valvular Microbiota and Valvulopathy

NCT06407128 | Recruiting

• 1 other identifier: RC31/22/0108
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvulopathy

Keywords

Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Collection of biological samples

EXPERIMENTAL

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.

Biological: Collection of biological samples

Interventions

Collection of biological samples BIOLOGICAL

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

Collection of biological samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jean PORTERIE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean PORTERIE, MD

CONTACT

5 61 32 24 12; porterie.j@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)