Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function (Tri-GuM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tricuspid Regurgitation (TR)

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Clinical Trial Coordinator; Phone Number: +39 0226435316; Email: schiavi.davide@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele
    • Contact: Clinical Trial Coordinator; Phone Number: +390226435316; Email: schiavi.davide@hsr.it
    • Contact: Francesco Maisano, Professor
    • Contact: Silvio Danese, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with TR ≥ severe who will undergo T-TEER

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
T-TEER; Adult patients, able to sign the Informed Consent Form, with TR ≥ severe who will be treated with T-TEER

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiota Changes	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	3 months

Collaborators and Investigators

• Sponsor: Francesco Maisano
• Collaborators: Abbott; IRCCS Ospedale San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: gut microbiota; heart; gastrointestinal; tricuspid regurgitation; heart valve disease; transcatheter; tricuspid valve disease; T-TEER
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: Tri-GuM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes