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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muhammed Gercek
- 전화번호: 0049571971258
- 이메일: mugercek@hdz-nrw.de
연구 장소
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, 독일, 32545
- 모병
- Herz- und Diabeteszentrum NRW
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Gut Microbial Metabolite Plasma Levels
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Plasma Levels of Gut Microbial Metabolites at 30 Days
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
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