Tricuspid Cardiopulmonary Exercise Study (NCT04559256) | Clinical Trial Compass
CompletedNot Applicable
Tricuspid Cardiopulmonary Exercise Study
Germany30 participantsStarted 2020-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Influence of transcatheter tricuspid intervention on peak oxygen uptake
Timeframe: 3 month
2
Influence of transcatheter tricuspid intervention on duration of submaximal exercise tolerance
Timeframe: 3 month
Trial details
NCT IDNCT04559256
SponsorHeart and Diabetes Center North-Rhine Westfalia