Gut Microbial Metabolites and Intestinal Permeability in Patients With Severe Tricuspid Regurgitation Undergoing Transcatheter Tricuspid Valve Intervention (INTEGRITY)
MicrobIal Metabolites and Gut Leakiness assessmeNT in Patients With sevEre Tricuspid reGuRgItation Undergoing Transcatheter Tricuspid Valve inTervention: a Multidimensional analYsis (INTEGRITY-Trial)
Emerging evidence highlights a bidirectional gut-heart axis, particularly relevant in patients with right heart failure. Elevated right atrial pressures and systemic congestion may impair intestinal perfusion and compromise epithelial integrity, leading to increased gut permeability ("leaky gut") and translocation of microbial products. These processes can trigger systemic inflammation and exacerbate cardiac dysfunction. Alterations in the gut microbiome-collectively referred to as dysbiosis-have also been linked to heart failure pathogenesis. However, the role of intestinal barrier dysfunction and microbial signatures in patients with severe tricuspid regurgitation (TR) remains largely unexplored.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Muhammed Gercek
- 电话号码：0049571971258
- 邮箱：mugercek@hdz-nrw.de
学习地点
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North Rhine-Westphalia
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Bad Oeynhausen、North Rhine-Westphalia、德国、32545
- 招聘中
- Herz- und Diabeteszentrum NRW
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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• Patients with functional tricuspid regurgitation (TR) who were evaluated for transcatheter tricuspid valve intervention
- Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Patients undergoing PFO closure without any other known comorbidities will serve as control group
Exclusion Criteria:
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• Previous tricuspid valve repair or replacement
- Echocardiographic evaluation not available or not suitable for analysis at baseline
- Key information from patients (e.g. NYHA, TR grade) not available
- Known allergy or intolerance against the studied device
- Persons held in an institution by legal or official order
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：TTVI Cohort
Patients with severe functional tricuspid regurgitation undergoing transcatheter tricuspid valve intervention (TTVI) as part of routine clinical care. The decision to perform TTVI is made independently of study participation. Patients undergo longitudinal assessment of gut microbial metabolites, intestinal permeability, and clinical parameters. |
transcatheter tricuspid valve intervention |
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有源比较器：PFO Control Cohort
relevant comorbidities or heart failure. The decision to perform PFO closure is made independently of study participation. This cohort serves as a reference group for the assessment of gut microbial metabolite profiles and intestinal permeability. |
Patent Foramen Ovale (PFO) Closure |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Gut Microbial Metabolite Plasma Levels
大体时间：Baseline (prior to intervention) and 6 months post-intervention (180 ± 14 days)
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Change in plasma concentrations of gut microbial metabolites from baseline to 6 months after intervention, assessed by liquid chromatography-tandem mass spectrometry (LC-MS/MS). |
Baseline (prior to intervention) and 6 months post-intervention (180 ± 14 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Plasma Levels of Gut Microbial Metabolites at 30 Days
大体时间：Baseline and 30 days post-intervention
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Changes in plasma concentrations of gut microbial metabolites from baseline to 30 days after intervention, quantified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). |
Baseline and 30 days post-intervention
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Change in Intestinal Permeability at 6 Months
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Changes in intestinal permeability from baseline to 6 months after intervention, assessed using a differential sugar absorption test with lactulose, rhamnose, and sucrose. |
Baseline and 6 months post-intervention (180 ± 14 days)
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Moderate-to-Severe or Severe Tricuspid Regurgitation at 30 Days
大体时间：30 days post-intervention
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Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography. |
30 days post-intervention
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Moderate-to-Severe or Severe Tricuspid Regurgitation at 6 Months
大体时间：6 months post-intervention (180 ± 14 days)
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Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography. |
6 months post-intervention (180 ± 14 days)
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All-Cause Mortality
大体时间：From intervention up to 6 months post-intervention
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Number of participants who die from any cause during the follow-up period. |
From intervention up to 6 months post-intervention
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Heart Failure Rehospitalization
大体时间：From intervention up to 6 months post-intervention
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Number of participants experiencing at least one rehospitalization due to worsening heart failure during the follow-up period. |
From intervention up to 6 months post-intervention
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Change in New York Heart Association (NYHA) Functional Class
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in NYHA functional class from baseline to 6 months after intervention. NYHA functional class ranges from I (no limitation of physical activity) to IV (symptoms at rest). A lower class indicates better functional status. |
Baseline and 6 months post-intervention (180 ± 14 days)
|
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6 months after intervention. Scores range from 0 to 100, with higher scores indicating better health status. |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Levels
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in serum NT-proBNP concentration from baseline to 6 months after intervention, assessed using laboratory blood analysis. |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Right Ventricular Basal Diameter
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in right ventricular basal diameter from baseline to 6 months after intervention, assessed by transthoracic echocardiography. Measurements are expressed in millimeters (mm). |
Baseline and 6 months post-intervention (180 ± 14 days)
|
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Change in Right Ventricular Fractional Area Change (RV FAC)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in right ventricular fractional area change from baseline to 6 months after intervention, assessed by transthoracic echocardiography as a measure of right ventricular systolic function. Measurements are expressed as percentages (%). |
Baseline and 6 months post-intervention (180 ± 14 days)
|
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Change in Right Ventricular Global Longitudinal Strain (RV GLS)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in right ventricular global longitudinal strain from baseline to 6 months after intervention, assessed by transthoracic echocardiography using speckle-tracking analysis. Measurements are expressed as percentages (%). |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in tricuspid annular plane systolic excursion from baseline to 6 months after intervention, assessed by transthoracic echocardiography as a measure of right ventricular longitudinal systolic function. Measurements are expressed in millimeters (mm). |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Estimated Systolic Pulmonary Artery Pressure (sPAP)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in estimated systolic pulmonary artery pressure from baseline to 6 months after intervention, assessed by transthoracic echocardiography using the tricuspid regurgitation jet pressure gradient and estimated central venous pressure. Measurements are expressed in millimeters of mercury (mmHg). |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Left Ventricular Ejection Fraction (LVEF)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in left ventricular ejection fraction from baseline to 6 months after intervention, assessed by transthoracic echocardiography using the biplane Simpson method. Measurements are expressed as percentages (%). |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Left Ventricular End-Systolic Volume (LVESV)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in left ventricular end-systolic volume from baseline to 6 months after intervention, assessed by transthoracic echocardiography. Measurements are expressed in milliliters (mL). |
Baseline and 6 months post-intervention (180 ± 14 days)
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Change in Left Ventricular End-Diastolic Volume (LVEDV)
大体时间：Baseline and 6 months post-intervention (180 ± 14 days)
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Change in left ventricular end-diastolic volume from baseline to 6 months after intervention, assessed by transthoracic echocardiography. Measurements are expressed in milliliters (mL). |
Baseline and 6 months post-intervention (180 ± 14 days)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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