Tricuspid Cardiopulmonary Exercise Study

NCT04559256 | Completed

• 1 other identifier: HDZ-KA_018_MG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tricuspid Regurgitation

Keywords

Tricuspid Regurgitation; Cardiopulmonary Exercise Testing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Influence of transcatheter tricuspid intervention on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing

  3 month

• Prevalence of oscillatory respiration pattern

  3 month

• Exercise Testing with 6 min walking test

  3 month

• Prevalence of moderate to severe or severe tricuspid regurgitation

  3 month

• Rehospitalization rate for heart failure

  3 month

Study Arms (1)

Tricuspid Cardiopulmonary Exercise testing

OTHER

Patient receiving cardiopulmonary exercise testing

Diagnostic Test: Cardiopulmonary Exercise Testing

Interventions

Cardiopulmonary Exercise Testing DIAGNOSTIC_TEST

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

Tricuspid Cardiopulmonary Exercise testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Muhammed Gerçek, MD

  Heart and Diabetes Center North-Rhine Westfalia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: January 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)