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NCT Number: NCT06902922

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, Italy, 20132

Location contact

Clinical Trial Coordinator

CONTACT

[email protected]

+390226435316

Francesco Maisano, Professor

PRINCIPAL_INVESTIGATOR

Silvio Danese, Professor

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Gut Microbiota Changes

    Time frame: 3 months

    The microbiota metabolites production in patients affected by severe TR and their changes after transcatheter TR correction will be measured at 3-months, compared to baseline, in terms of c differential abundance in microbiota metabolites, according to residual TR groups

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Coordinator

CONTACT

[email protected]

+39 0226435316

Sponsors and collaborators

Lead sponsor

Francesco Maisano

Other

Collaborators

  • Abbott
  • IRCCS Ospedale San Raffaele

Registry information

Acronym: Tri-GuM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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