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Completed

NCT Number: NCT04559256

Tricuspid Cardiopulmonary Exercise Study

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.

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiopulmonary exercise testing

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Prevalence of oscillatory respiration pattern

    Time frame: 3 month

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

  3. Exercise Testing with 6 min walking test

    Time frame: 3 month

    Changes on walked distance after transcatheter tricuspid intervention

  4. 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

  5. Rehospitalization rate for heart failure

    Time frame: 3 month

    Detection of rehospitalization rate after transcatheter tricuspid intervention

  6. Influence of transcatheter tricuspid intervention on NYHA class

    Time frame: 3 month

    Changes on NYHA class after transcatheter tricuspid intervention

  7. 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)

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study title

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

Acronym: TRCPET

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Sep 22, 2020
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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