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Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities

Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04570098
Enrollment
1016
Registered
2020-09-30
Start date
2020-07-26
Completion date
2024-09-30
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Tricuspid Regurgitation

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

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall mortality3 months after enrolmentOverall mortality after 3 months (number of deceased patients)

Secondary

MeasureTime frameDescription
hospitalization due to cardiac decompensation3 months after enrolmentnumber of hospitalized patients after 3 months
exercise capacity according to NYHA classification3 months after enrolment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026