Clinical trial NCT04559256: Tricuspid Cardiopulmonary Exercise Study
Official title: Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Cardiopulmonary Exercise Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: Tricuspid Regurgitation
Cardiopulmonary Exercise Testing
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Influence of transcatheter tricuspid intervention on peak oxygen uptake
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on duration of submaximal exercise tolerance
timeFrame: 3 month
Secondary outcomes:
measure: Influence of transcatheter tricuspid intervention on the minute ventilation/carbon dioxide production slope in the cardiopulmonary exercise testing
timeFrame: 3 month
measure: Prevalence of oscillatory respiration pattern
timeFrame: 3 month
measure: Exercise Testing with 6 min walking test
timeFrame: 3 month
measure: Prevalence of moderate to severe or severe tricuspid regurgitation
timeFrame: 3 month
measure: Rehospitalization rate for heart failure
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on NYHA class
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on quality of life
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on the left an right ventricle
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on serum N terminal-proBNP level
timeFrame: 3 month
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum, NRW
state: NRW
Study officials:
affiliation: Heart and Diabetes Center North-Rhine Westfalia
name: Muhammed Gerçek, MD
role: PRINCIPAL_INVESTIGATOR
References: