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

NCT06902922 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-03-30

No results posted yet for this study

Summary

Tricuspid regurgitation (TR) is gaining increasing attention within the cardiological community due to its poor prognosis, challenging clinical presentation and difficult treatment.

TR causes decreased forward cardiac output and increased intravascular pressure upstream, which lead to peripheral oedema, ascites, hepatic congestion and kidney failure.

The microbiota is also getting increasing attention and changes in microbiota have been already associated with cardiovascular disease.

The impact of hemodynamic effects of TR on the gut microbiota however is still unknown.

Patients affected by TR frequently complain abdominal distension and anorexia. We hypothesize that, due to increased venous congestion, TR may induce impaired gut function with modification in the microbiota and that TR correction may induce reverse changes.

This study will enroll patients treated with Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER) at the Valve Center of San Raffaele Hospital due to severe TR.

In addition to the standard of care, before T-TEER, for all patients 2 additional blood samples, 1 urine and 1 fecal sample will be collected.

3 months after the procedure, all patients will be re-assessed at the Valve Center outpatient clinic as standard of care. At this stage for all patients 2 blood samples, 1 urine and 1 fecal sample will be collected again for the purpose of the study. The microbiota metabolites of patients after 3 months from the procedure will be compared to those at baseline according to the degrees of residual TR.

To assess the reproducibility of the microbiota results and to explore an intrinsic short-term variation in microbiome composition within single patients, a subgroup of 30 patients will undergo a low intervention substudy repeating the measurements (2 blood, 1 urine and 1 fecal) within 10 days, both at baseline and at follow-up.

Conditions

  • Tricuspid Regurgitation (TR)

Sponsors & Collaborators

  • IRCCS Ospedale San Raffaele

    collaborator OTHER

  • Abbott

    collaborator INDUSTRY

  • Francesco Maisano

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • Italy

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902922 on ClinicalTrials.gov