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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Muhammed Gercek
- Telefonszám: 0049571971258
- E-mail: mugercek@hdz-nrw.de
Tanulmányi helyek
-
-
North Rhine-Westphalia
-
Bad Oeynhausen, North Rhine-Westphalia, Németország, 32545
- Toborzás
- Herz- und Diabeteszentrum NRW
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Aktív összehasonlító: 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 |
|
Aktív összehasonlító: 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 |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Gut Microbial Metabolite Plasma Levels
Időkeret: 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)
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Plasma Levels of Gut Microbial Metabolites at 30 Days
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
|
Együttműködők és nyomozók
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- HDZ-KA_0525_INTEGRITY
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .