TRCPET: Tricuspid Cardiopulmonary Exercise Study

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04559256
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Regurgitation	Diagnostic Test: Cardiopulmonary Exercise Testing	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Cardiopulmonary Exercise Testing
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Influence of transcatheter tricuspid intervention on peak oxygen uptake [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 [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 Outcome Measures

1. Influence of transcatheter tricuspid intervention on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing [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 [3 month]

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

3. Exercise Testing with 6 min walking test [3 month]

   Changes on walked distance after transcatheter tricuspid intervention

4. Prevalence of moderate to severe or severe tricuspid regurgitation [3 month]

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

5. Rehospitalization rate for heart failure [3 month]

   Detection of rehospitalization rate after transcatheter tricuspid intervention

6. Influence of transcatheter tricuspid intervention on NYHA class [3 month]

   Changes on NYHA class after transcatheter tricuspid intervention

7. Influence of transcatheter tricuspid intervention on quality of life [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 [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 [3 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herz- und Diabeteszentrum, NRW	Bad Oeynhausen	NRW	Germany	32545

Sponsors and Collaborators

• Heart and Diabetes Center North-Rhine Westfalia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammed Gerçek, Principal Investigator, Heart and Diabetes Center North-Rhine Westfalia
• ClinicalTrials.gov Identifier: NCT04559256
• Other Study ID Numbers: HDZ-KA_018_MG
• First Posted: Sep 22, 2020
• Last Update Posted: Oct 26, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Muhammed Gerçek, Principal Investigator, Heart and Diabetes Center North-Rhine Westfalia: Tricuspid Regurgitation; Cardiopulmonary Exercise Testing
• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Oct 26, 2021