Analyzing blood microbiota in patients undergoing aortic valve replacement
Valvular Microbiota and Valvulopathy
This study is testing if the bacteria found in the blood of patients having aortic valve replacement can help predict how well they will recover and if they will face any complications after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06407128 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the relationship between blood microbiota and tissue microbiota in patients scheduled for aortic valve replacement due to degenerative aortic valve disease. The researchers will collect biological samples to analyze the microbiota present in the blood, which may serve as a biomarker for the tissue microbiota. The goal is to determine if this analysis can predict post-operative outcomes and complications within one year. This study represents a pioneering effort to understand the role of microbiota in valvular degeneration associated with aging.
Who should consider this trial
Good fit: Ideal candidates include patients with symptomatic or asymptomatic severe aortic stenosis or regurgitation who are indicated for surgical aortic valve replacement.
Not a fit: Patients who do not require aortic valve replacement or have other underlying conditions that complicate their heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new biomarker to guide treatment strategies and improve post-operative outcomes for patients undergoing aortic valve replacement.
How similar studies have performed: While the analysis of microbiota in relation to valvular disease is a novel approach, there is limited existing research specifically targeting this relationship in the context of aortic valve replacement.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse
- University Hospital — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Jean PORTERIE, MD — University Hospital, Toulouse
- Study coordinator: Jean PORTERIE, MD
- Email: porterie.j@chu-toulouse.fr
- Phone: 5 61 32 24 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.