Valvular Microbiota and Valvulopathy

Launched by UNIVERSITY HOSPITAL, TOULOUSE · May 6, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Valvular Microbiota and Valvulopathy," is exploring how the bacteria found in our blood may be linked to heart valve diseases, specifically for patients needing surgery to replace their aortic valve. The researchers believe that understanding these bacteria could help doctors make better decisions about treatment both before and after the surgery. This study aims to see if the bacteria in the blood can indicate the presence of bacteria in the heart tissue for patients undergoing aortic valve replacement due to age-related valve problems.

To be eligible for the trial, participants must be between 65 to 74 years old and have specific heart conditions that require surgical intervention, such as severe narrowing of the aortic valve or dysfunction of the heart's left ventricle. Those who join the study will have their blood analyzed, and their progress will be monitored for a year after surgery to see how these bacteria affect recovery and potential complications. This trial is important because it could be the first step in understanding how bacteria in our bodies contribute to heart valve issues, especially as we age.

Gender

ALL

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.