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Gut Microbial Metabolites and Intestinal Permeability in Patients With Severe Tricuspid Regurgitation Undergoing Transcatheter Tricuspid Valve Intervention (INTEGRITY)

8 november 2026 uppdaterad av: Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Tyskland
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Tyskland, 32545
        • Rekrytering
        • Herz- und Diabeteszentrum NRW

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Procedur: transcatheter tricuspid valve intervention

transcatheter tricuspid valve intervention
Aktiv komparator: 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.
Procedur: PFO Control Cohort

Patent Foramen Ovale (PFO) Closure

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Gut Microbial Metabolite Plasma Levels
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Plasma Levels of Gut Microbial Metabolites at 30 Days
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)

Samarbetspartners och utredare

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Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 september 2025

Primärt slutförande (Beräknad)

1 juni 2029

Avslutad studie (Beräknad)

1 juni 2029

Studieregistreringsdatum

Först inskickad

11 augusti 2025

Först inskickad som uppfyllde QC-kriterierna

8 november 2026

Första postat (Faktisk)

12 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

8 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HDZ-KA_0525_INTEGRITY

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