IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Location contact
Clinical Trial Coordinator
CONTACT
Francesco Maisano, Professor
PRINCIPAL_INVESTIGATOR
Silvio Danese, Professor
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06902922
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Milan, Italy, 20132
Clinical Trial Coordinator
CONTACT
Francesco Maisano, Professor
PRINCIPAL_INVESTIGATOR
Silvio Danese, Professor
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Contact information is provided by the study sponsor or research team.
Francesco Maisano
Other
Acronym: Tri-GuM
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