Tricuspid Cardiopulmonary Exercise Study (TRCPET)

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: Active, not recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Diagnostic test: Cardiopulmonary Exercise Testing

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammed Gerçek, MD; Phone Number: 05731970; Email: mugercek@hdz-nrw.de

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	3 month
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	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 month
Prevalence of oscillatory respiration pattern	Detection of oscillatory respiration pattern before and 3 months after transcatheter tricuspid intervention	3 month
Exercise Testing with 6 min walking test	Changes on walked distance after transcatheter tricuspid intervention	3 month
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	3 month
Rehospitalization rate for heart failure	Detection of rehospitalization rate after transcatheter tricuspid intervention	3 month
Influence of transcatheter tricuspid intervention on NYHA class	Changes on NYHA class after transcatheter tricuspid intervention	3 month
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)	3 month
Influence of transcatheter tricuspid intervention on the left an right ventricle	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	Changes on serum N terminal-proBNP-level after transcatheter tricuspid intervention	3 month

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Investigators: Principal Investigator: Muhammed Gerçek, MD, Heart and Diabetes Center North-Rhine Westfalia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Tricuspid Regurgitation; Cardiopulmonary Exercise Testing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID 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