Gut Microbial Metabolites and Intestinal Permeability in Patients With Severe Tricuspid Regurgitation Undergoing Transcatheter Tricuspid Valve Intervention
NCT07933198, Not applicable, Recruiting, Heart and Diabetes Center North-Rhine Westfalia
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Gut Microbial Metabolites and Intestinal Permeability in Patients With Severe Tricuspid Regurgitation Undergoing Transcatheter Tricuspid Valve Intervention | ClinicalTrials.gov |
| NCT number | NCT07933198 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Heart and Diabetes Center North-Rhine Westfalia | ClinicalTrials.gov |
| Conditions | Tricuspid Valve Regurgitation | ClinicalTrials.gov |
| Interventions | transcatheter tricuspid valve intervention, PFO Control Cohort | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Gut Microbial Metabolite Plasma Levels | 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). | ClinicalTrials.gov |
| Secondary | Change in Plasma Levels of Gut Microbial Metabolites at 30 Days | 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). | ClinicalTrials.gov |
| Secondary | Change in Intestinal Permeability at 6 Months | 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. | ClinicalTrials.gov |
| Secondary | Moderate-to-Severe or Severe Tricuspid Regurgitation at 30 Days | 30 days post-intervention | Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography. | ClinicalTrials.gov |
| Secondary | Moderate-to-Severe or Severe Tricuspid Regurgitation at 6 Months | 6 months post-intervention (180 ± 14 days) | Number of participants with moderate-to-severe or severe TR assessed by transthoracic echocardiography. | ClinicalTrials.gov |
| Secondary | All-Cause Mortality | From intervention up to 6 months post-intervention | Number of participants who die from any cause during the follow-up period. | ClinicalTrials.gov |
| Secondary | Heart Failure Rehospitalization | 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. | ClinicalTrials.gov |
| Secondary | Change in New York Heart Association (NYHA) Functional Class | 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. | ClinicalTrials.gov |
| Secondary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score | 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. | ClinicalTrials.gov |
| Secondary | Change in Serum N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Levels | 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. | ClinicalTrials.gov |
| Secondary | Change in Right Ventricular Basal Diameter | 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). | ClinicalTrials.gov |
| Secondary | Change in Right Ventricular Fractional Area Change (RV FAC) | 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 (%). | ClinicalTrials.gov |
| Secondary | Change in Right Ventricular Global Longitudinal Strain (RV GLS) | 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 (%). | ClinicalTrials.gov |
| Secondary | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) | 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). | ClinicalTrials.gov |
| Secondary | Change in Estimated Systolic Pulmonary Artery Pressure (sPAP) | 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). | ClinicalTrials.gov |
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) | 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 (%). | ClinicalTrials.gov |
| Secondary | Change in Left Ventricular End-Systolic Volume (LVESV) | 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). | ClinicalTrials.gov |
| Secondary | Change in Left Ventricular End-Diastolic Volume (LVEDV) | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)