An observational study in Tricuspid Regurgitation and Heart Failure, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Charite University, Berlin, Germany · Observational
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.
Moderate to severe tricuspid regurgitation (TR) is a frequent result of left heart failure causing a limiting prognosis. The new interventional therapies have given more relevance to the questions of the prognostic significance of severe TR in the various heart failure entities.
Important but currently unanswered questions for the establishment of successful, interventional therapies of TR are:
In addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. A comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies.
Primary endpoint: death Secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to NYHA classification
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 1,016 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population include patients with heart failure (all three entities). All patients will be examined with an echocardiography at the Charité, followed by long-term observation to assess the prognostic relevance of tricuspid regurgitation in heart failure.
Exclusion Criteria:
Overall mortality
Overall mortality after 3 months (number of deceased patients)
Time frame: 3 months after enrolment
Overall mortality
Overall mortality after 24 months (number of deceased patients)
Time frame: 24 months after enrolment
hospitalization due to cardiac decompensation
number of hospitalized patients after 3 months
Time frame: 3 months after enrolment
exercise capacity according to NYHA classification
Time frame: 3 months after enrolment
hospitalization due to cardiac decompensation
number of hospitalized patients after 24 months
Time frame: 24 months after enrolment
exercise capacity according to NYHA classification
Time frame: 24 months after enrolment
Plan to share: Yes — As part of the expected publications, it is planned to provide data of the study participants and more detailed information on inclusion and exclusion criteria (study protocol).
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany