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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04570098
• Other study ID #: EA1/178/19
• Status: Active, not recruiting
• Start date: July 26, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1016
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	Overall mortality after 3 months (number of deceased patients)	3 months after enrolment
Primary	Overall mortality	Overall mortality after 24 months (number of deceased patients)	24 months after enrolment
Secondary	hospitalization due to cardiac decompensation	number of hospitalized patients after 3 months	3 months after enrolment
Secondary	exercise capacity according to NYHA classification		3 months after enrolment
Secondary	hospitalization due to cardiac decompensation	number of hospitalized patients after 24 months	24 months after enrolment
Secondary	exercise capacity according to NYHA classification		24 months after enrolment