NCT04570098

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,016 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tricuspid Regurgitation
• Heart Failure

Timeline

• Start date: 2020-07-26
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2020-09-30
• Last updated: 2025-02-12

Locations

1 site across 1 country: Germany