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

NCT06902922 | Not Yet Recruiting

• 1 other identifier: Tri-GuM
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

tricuspid regurgitation; gut microbiota; gastrointestinal; heart; heart valve disease; tricuspid valve disease; transcatheter; T-TEER

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

T-TEER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.

You may not qualify if:

• 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

Sponsors & Collaborators

• Francesco Maisano: lead
• IRCCS Ospedale San Raffaele: collaborator
• Abbott: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Clinical Trial Coordinator

CONTACT

+39 0226435316; schiavi.davide@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Cardiac Surgery Department; Director of the Heart Valve Center

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)