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临床试验/NCT06902922
NCT06902922尚未招募不适用

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

Francesco Maisano1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Gut Microbiota Changes

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Gut Microbiota Changes

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Francesco Maisano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francesco Maisano

Head of Cardiac Surgery Department; Director of the Heart Valve Center

IRCCS Ospedale San Raffaele

研究点 (1)

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