AzTrials
AzTrials

Tricuspid RegurgitationTRCPETNCT04559256

Tricuspid Cardiopulmonary Exercise Study

A study testing Cardiopulmonary Exercise Testing in people with Tricuspid Regurgitation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tricuspid Regurgitation
What is being tested?
Cardiopulmonary Exercise Testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
1 Jan 2020to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Herz- und Diabeteszentrum, NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545

Other trials in Germany

About this study

Official title: 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.

Being tested
Cardiopulmonary Exercise Testing
Keywords
Tricuspid Regurgitation, Cardiopulmonary Exercise Testing
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiopulmonary Exercise TestingDiagnostic test

    Patients will receive a cardiopulmonary exercise testing before and 3-month after tricuspid intervention

Study groups in NCT04559256
Study groupRoleWhat they receive
Tricuspid Cardiopulmonary Exercise testingOtherPatient receiving cardiopulmonary exercise testing
Receives: Diagnostic Test: Cardiopulmonary Exercise Testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Influence of transcatheter tricuspid intervention on peak oxygen uptake

    Changes on maximal oxygen uptake (peak VO2) assessed by cardiopulmonary exercise testing (CPET, spiroergometry) after transcatheter tricuspid intervention

    Measured: 3 month

  2. Influence of transcatheter tricuspid intervention on duration of submaximal exercise tolerance

    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

    Measured: 3 month

Secondary outcomes (9)

  1. Influence of transcatheter tricuspid intervention on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing

    Changes on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing after transcatheter tricuspid intervention

    Measured: 3 month

  2. Prevalence of oscillatory respiration pattern

    Detection of oscillatory respiration pattern before and 3 months after transcatheter tricuspid intervention

    Measured: 3 month

  3. Exercise Testing with 6 min walking test

    Changes on walked distance after transcatheter tricuspid intervention

    Measured: 3 month

  4. Prevalence of moderate to severe or severe tricuspid regurgitation

    Detection of the prevalence of moderate to severe or severe tricuspid regurgitation after transcatheter tricuspid intervention

    Measured: 3 month

  5. Rehospitalization rate for heart failure

    Detection of rehospitalization rate after transcatheter tricuspid intervention

    Measured: 3 month

  6. Influence of transcatheter tricuspid intervention on NYHA class

    Changes on NYHA class after transcatheter tricuspid intervention

    Measured: 3 month

  7. Influence of transcatheter tricuspid intervention on quality of life

    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)

    Measured: 3 month

  8. Influence of transcatheter tricuspid intervention on the left an right ventricle

    Echocardiographic assessment of left and right ventricular remodeling after transcatheter tricuspid intervention

    Measured: 3 month

  9. Influence of transcatheter tricuspid intervention on serum N terminal-proBNP level

    Changes on serum N terminal-proBNP-level after transcatheter tricuspid intervention

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start1 Jan 2020
  3. Primary completion1 Aug 2022
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559256
Sponsor's protocol ID
HDZ-KA_018_MG
Acronym
TRCPET
Status last verified
Mar 2025
First submitted
16 Sep 2020
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cardiopulmonary Exercise Testing in people with Tricuspid Regurgitation, run by Heart and Diabetes Center North-Rhine Westfalia at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Influence of transcatheter tricuspid intervention on peak oxygen uptake (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in