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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muhammed Gercek
- 電話番号：0049571971258
- メール：mugercek@hdz-nrw.de
研究場所
-
-
North Rhine-Westphalia
-
Bad Oeynhausen、North Rhine-Westphalia、ドイツ、32545
- 募集
- Herz- und Diabeteszentrum NRW
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
• 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:
-
• 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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 |
|
アクティブコンパレータ：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Gut Microbial Metabolite Plasma Levels
時間枠：Baseline (prior to intervention) and 6 months post-intervention (180 ± 14 days)
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Plasma Levels of Gut Microbial Metabolites at 30 Days
時間枠：Baseline and 30 days post-intervention
|
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
|
|
Change in Intestinal Permeability at 6 Months
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Moderate-to-Severe or Severe Tricuspid Regurgitation at 30 Days
時間枠：30 days post-intervention
|
Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography. |
30 days post-intervention
|
|
Moderate-to-Severe or Severe Tricuspid Regurgitation at 6 Months
時間枠：6 months post-intervention (180 ± 14 days)
|
Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography. |
6 months post-intervention (180 ± 14 days)
|
|
All-Cause Mortality
時間枠：From intervention up to 6 months post-intervention
|
Number of participants who die from any cause during the follow-up period. |
From intervention up to 6 months post-intervention
|
|
Heart Failure Rehospitalization
時間枠：From intervention up to 6 months post-intervention
|
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
|
|
Change in New York Heart Association (NYHA) Functional Class
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Levels
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Right Ventricular Basal Diameter
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Right Ventricular Fractional Area Change (RV FAC)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Right Ventricular Global Longitudinal Strain (RV GLS)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Estimated Systolic Pulmonary Artery Pressure (sPAP)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Left Ventricular Ejection Fraction (LVEF)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Left Ventricular End-Systolic Volume (LVESV)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
|
Change in Left Ventricular End-Diastolic Volume (LVEDV)
時間枠：Baseline and 6 months post-intervention (180 ± 14 days)
|
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)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。