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

Completed

• Conditions: Heart Failure; Tricuspid Regurgitation

• Registration Number: NCT04570098
• Lead Sponsor: Charite University, Berlin, Germany

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

Study Timeline

• Study Start: 2020-07-26
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1016

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality	24 months after enrolment	Overall mortality after 24 months (number of deceased patients)

Secondary Outcome Measures

Name	Time	Method
hospitalization due to cardiac decompensation	24 months after enrolment	number of hospitalized patients after 24 months
exercise capacity according to NYHA classification	24 months after enrolment

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany