Tricuspid Regurgitation (TR)Tri-GuMNCT06902922
Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function
An observational study of Tricuspid Regurgitation (TR), run by Francesco Maisano at 1 site in Italy.
Trial summary
Tricuspid regurgitation (TR) is gaining increasing attention within the cardiological community due to its poor prognosis, challenging clinical presentation and difficult treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with TR ≥ severe who will undergo T-TEER
Who may be able to join
- Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Clinical Trial Coordinator, +390226435316, schiavi.davide@hsr.it
Francesco Maisano, Professor
About this study
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.
Read more
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
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T-TEER | Adult patients, able to sign the Informed Consent Form, with TR ≥ severe who will be treated with T-TEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start31 Mar 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesco Maisano
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Ospedale San Raffaele, Abbott
- Responsible party
- Sponsor-investigator, Francesco Maisano, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902922
- Sponsor's protocol ID
- Tri-GuM
- Acronym
- Tri-GuM
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function
- ClinicalTrials.gov ID
- NCT06902922
- Acronym / sponsor ID
- Tri-GuM / Tri-GuM
- Conditions
- Tricuspid Regurgitation (TR)
- Keywords
- tricuspid regurgitation, gut microbiota, gastrointestinal, heart, heart valve disease, tricuspid valve disease, transcatheter, T-TEER
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Francesco MaisanoUniversity, hospital or other
- Collaborators
- IRCCS Ospedale San Raffaele, Abbott
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-TEER | – | –Adult patients, able to sign the Informed Consent Form, with TR ≥ severe who will be treated with T-TEER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with TR ≥ severe who will undergo T-TEER
Key inclusion criteria (1 listed)
- Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation (TR), run by Francesco Maisano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Coordinator (+39 0226435316, schiavi.davide@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiota Changes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.