Tricuspid Cardiopulmonary Exercise Study (TRCPET)

March 10, 2025 updated by: Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia

Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Cardiopulmonary Exercise Testing

Tricuspid regurgitation (TR), which in close to 90% of cases is functional as a consequence of left-sided heart failure, left heart valve abnormalities or pulmonary (vascular) disease, is associated with adverse patient outcomes . Due to the increased risk of surgical tricuspid valve repair or replacement compared to surgery in left-sided valve disease TR is often undertreated. Treatment options for the tricuspid valve have so far been limited. Conservative therapy over longer. periods usually results in refractoriness to diuretic treatment. Surgical therapy is associated with a high rate of in-hospital mortality (8.8%), the cause of which is not yet fully understood but may partly be explained by the hemodynamic challenge that cardiopulmonary bypass imposes on the often already-dysfunctional right ventricle. Recently, transcatheter strategies have been developed and have shown promising results. Despite the promising data it has so far not be determined objectively whether interventional treatment of isolated tricuspid regurgitation improves exercise capacity and what role right ventricular function plays in this setting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Herz- und Diabeteszentrum, NRW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic tricuspid regurgitation 2+ to 4+ on a scale of 4+ (moderate to severe) with annular diameter ≥ 40 mm with valve systolic pulmonary pressure (sPAP) ≤ 60 mmHg
  • New York Heart Association (NYHA) Class II-IV
  • Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
  • Left ventricular ejection fraction ≥ 30%
  • Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen
  • The local site Heart Team concur that surgery will not be offered as a treatment option
  • Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

  • Inability to perform cardiopulmonary exercise test
  • Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate
  • Previous tricuspid valve repair or replacement
  • Severe precapillary pulmonary hypertension (PVR>6 WE)
  • Cerebrovascular accident (CVA) within the past 6 months
  • Presence of trans-tricuspid pacemaker or defibrillator leads which cause impingement of the tricuspid valve leaflet as evaluated by echocardiography
  • Subject is on chronic dialysis and/or anemia (Hb < 9 g/L)
  • Myocardial infarction or known unstable angina within 30 days prior to the index procedure
  • Any percutaneous coronary intervention or transcatheter valvular intervention within 30 days prior to the index procedure or planned 3 months post the index procedure
  • Previous tricuspid valve repair or replacement
  • Life expectancy of less than 12 months
  • Patients with cardiac cachexia
  • Echocardiographic evaluation not available or not suitable for analysis at baseline
  • Unsuitable anatomy for transcatheter tricuspid intervention
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Tricuspid Cardiopulmonary Exercise testing
Patient receiving cardiopulmonary exercise testing
Diagnostic test: Cardiopulmonary Exercise Testing
Patients will receive a cardiopulmonary exercise testing before and 3-month after tricuspid intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Influence of transcatheter tricuspid intervention on peak oxygen uptake
Time Frame: 3 month
Changes on maximal oxygen uptake (peak VO2) assessed by cardiopulmonary exercise testing (CPET, spiroergometry) after transcatheter tricuspid intervention
3 month
Influence of transcatheter tricuspid intervention on duration of submaximal exercise tolerance
Time Frame: 3 month
Changes on the duration of submaximal exercise tolerance assessed by exercise time during high-intensity constant-work rate endurance tests (CWRET) after transcatheter tricuspid intervention
3 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Influence of transcatheter tricuspid intervention on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing
Time Frame: 3 month
Changes on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing after transcatheter tricuspid intervention
3 month
Prevalence of oscillatory respiration pattern
Time Frame: 3 month
Detection of oscillatory respiration pattern before and 3 months after transcatheter tricuspid intervention
3 month
Exercise Testing with 6 min walking test
Time Frame: 3 month
Changes on walked distance after transcatheter tricuspid intervention
3 month
Prevalence of moderate to severe or severe tricuspid regurgitation
Time Frame: 3 month
Detection of the prevalence of moderate to severe or severe tricuspid regurgitation after transcatheter tricuspid intervention
3 month
Rehospitalization rate for heart failure
Time Frame: 3 month
Detection of rehospitalization rate after transcatheter tricuspid intervention
3 month
Influence of transcatheter tricuspid intervention on NYHA class
Time Frame: 3 month
Changes on NYHA class after transcatheter tricuspid intervention
3 month
Influence of transcatheter tricuspid intervention on quality of life
Time Frame: 3 month
Changes on the Minnesota Living with Heart Failure Questionnaire score after transcatheter tricuspid intervention (0-105 points on a global scale, with 0 points representing a very good quality of life and 105 points representing a very reduced quality of life)
3 month
Influence of transcatheter tricuspid intervention on the left an right ventricle
Time Frame: 3 month
Echocardiographic assessment of left and right ventricular remodeling after transcatheter tricuspid intervention
3 month
Influence of transcatheter tricuspid intervention on serum N terminal-proBNP level
Time Frame: 3 month
Changes on serum N terminal-proBNP-level after transcatheter tricuspid intervention
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heart and Diabetes Center North-Rhine Westfalia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammed Gerçek, MD, Heart and Diabetes Center North-Rhine Westfalia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HDZ-KA_018_MG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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