Clinical trial NCT04570098: Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
Official title: Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tricuspid Regurgitation
Heart Failure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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:

1. What effect does TR have on patients with heart failure?
2. Which patients at which stage of the disease benefit from interventional TR-therapies? In order to answer these questions, the aim of the study is to prospectively record the prevalence of TR (including quantification) in all heart failure patients at the Charité, followed by long-term observation to assess its prognostic relevance.

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

Eligibility criteria: Inclusion Criteria:

* Patients with transthoracic echocardiography (TTE) and heart failure
* Reported heart failure symptoms within the last two years
* \>18 years
* Written, documented consent

Exclusion Criteria:

- Patients in care or unable to consent

Primary outcomes:
measure: Overall mortality
timeFrame: 3 months after enrolment
measure: Overall mortality
timeFrame: 24 months after enrolment
Secondary outcomes:
measure: hospitalization due to cardiac decompensation
timeFrame: 3 months after enrolment
measure: exercise capacity according to NYHA classification
timeFrame: 3 months after enrolment
measure: hospitalization due to cardiac decompensation
timeFrame: 24 months after enrolment
measure: exercise capacity according to NYHA classification
timeFrame: 24 months after enrolment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References: