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Tricuspid Cardiopulmonary Exercise Study (TRCPET)

Primary Purpose

Tricuspid Regurgitation

Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cardiopulmonary Exercise Testing
Sponsored by
Heart and Diabetes Center North-Rhine Westfalia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Regurgitation focused on measuring Tricuspid Regurgitation, Cardiopulmonary Exercise Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herz- und Diabeteszentrum, NRW

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tricuspid Cardiopulmonary Exercise testing

Arm Description

Patient receiving cardiopulmonary exercise testing

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2020
Last Updated
March 3, 2023
Sponsor
Heart and Diabetes Center North-Rhine Westfalia
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1. Study Identification

Unique Protocol Identification Number
NCT04559256
Brief Title
Tricuspid Cardiopulmonary Exercise Study
Acronym
TRCPET
Official Title
Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Cardiopulmonary Exercise Testing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart and Diabetes Center North-Rhine Westfalia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 . 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Regurgitation
Keywords
Tricuspid Regurgitation, Cardiopulmonary Exercise Testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tricuspid Cardiopulmonary Exercise testing
Arm Type
Other
Arm Description
Patient receiving cardiopulmonary exercise testing
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiopulmonary Exercise Testing
Intervention Description
Patients will receive a cardiopulmonary exercise testing before and 3-month after tricuspid intervention
Primary Outcome Measure Information:
Title
Influence of transcatheter tricuspid intervention on peak oxygen uptake
Description
Changes on maximal oxygen uptake (peak VO2) assessed by cardiopulmonary exercise testing (CPET, spiroergometry) after transcatheter tricuspid intervention
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on duration of submaximal exercise tolerance
Description
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
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Influence of transcatheter tricuspid intervention on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing
Description
Changes on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing after transcatheter tricuspid intervention
Time Frame
3 month
Title
Prevalence of oscillatory respiration pattern
Description
Detection of oscillatory respiration pattern before and 3 months after transcatheter tricuspid intervention
Time Frame
3 month
Title
Exercise Testing with 6 min walking test
Description
Changes on walked distance after transcatheter tricuspid intervention
Time Frame
3 month
Title
Prevalence of moderate to severe or severe tricuspid regurgitation
Description
Detection of the prevalence of moderate to severe or severe tricuspid regurgitation after transcatheter tricuspid intervention
Time Frame
3 month
Title
Rehospitalization rate for heart failure
Description
Detection of rehospitalization rate after transcatheter tricuspid intervention
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on NYHA class
Description
Changes on NYHA class after transcatheter tricuspid intervention
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on quality of life
Description
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)
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on the left an right ventricle
Description
Echocardiographic assessment of left and right ventricular remodeling after transcatheter tricuspid intervention
Time Frame
3 month
Title
Influence of transcatheter tricuspid intervention on serum N terminal-proBNP level
Description
Changes on serum N terminal-proBNP-level after transcatheter tricuspid intervention
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammed Gerçek, MD
Organizational Affiliation
Heart and Diabetes Center North-Rhine Westfalia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herz- und Diabeteszentrum, NRW
City
Bad Oeynhausen
State/Province
NRW
ZIP/Postal Code
32545
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Tricuspid Cardiopulmonary Exercise Study

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