Tricuspid Cardiopulmonary Exercise Study

Tricuspid Regurgitation Clinical Trial

— TRCPET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04559256
• Other study ID #: HDZ-KA_018_MG
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 . 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Diagnostic Test:
• Cardiopulmonary Exercise Testing
Patients will receive a cardiopulmonary exercise testing before and 3-month after tricuspid intervention

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum, NRW	Bad Oeynhausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Prevalence of oscillatory respiration pattern	Detection of oscillatory respiration pattern before and 3 months after transcatheter tricuspid intervention	3 month
Secondary	Exercise Testing with 6 min walking test	Changes on walked distance after transcatheter tricuspid intervention	3 month
Secondary	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
Secondary	Rehospitalization rate for heart failure	Detection of rehospitalization rate after transcatheter tricuspid intervention	3 month
Secondary	Influence of transcatheter tricuspid intervention on NYHA class	Changes on NYHA class after transcatheter tricuspid intervention	3 month
Secondary	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
Secondary	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
Secondary	Influence of transcatheter tricuspid intervention on serum N terminal-proBNP level	Changes on serum N terminal-proBNP-level after transcatheter tricuspid intervention	3 month