Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function

Launched by FRANCESCO MAISANO · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how fixing a heart condition called severe tricuspid regurgitation (TR) affects the gut microbiota, which is the collection of bacteria and other microorganisms in our intestines. TR can lead to serious health issues, including swelling in the abdomen and poor digestion. Researchers want to understand if correcting TR with a specific procedure called Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER) improves gut health by changing the microbiota, which might also help with gastrointestinal (GI) function.

To participate in this study, patients must be adults experiencing severe TR and be able to give consent. They should not have other major heart or gastrointestinal diseases that could affect the results. Participants will provide blood, urine, and stool samples before and three months after their T-TEER procedure to help researchers compare the changes in their microbiota. This study aims to gather valuable insights that could improve treatment for patients with TR and related gut issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.
• Exclusion Criteria:
• • Concomitant ≥ severe MR. Such patients may be treated with M-TEER and be re-evaluated after 3 months: if TR is ≥ severe and MR is ≤ moderate the patient may then be enrolled.
• • Surgical candidates
• • Recent \< 6 months cardiac coronary or structural procedure
• • CAD requiring intervention
• • other valvular disease \> moderate
• • Treatment with transcatheter tricuspid replacement
• • Age \<18 years
• • Inability or unwillingness to sign informed consent
• • Kidney dialysis
• • Acute infection
• • Inflammatory bowel diseases
• • Gastrointestinal diseases
• • Previous gastrointestinal surgery
• • Active cancer
• • Active autoimmune or inflammatory diseases
• • Treatments with antibiotics or probiotics within one month
• • Emergency procedures
• • Patients enrolled in interventional studies that may confound study results