Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

Functional Tricuspid Regurgitation Clinical Trial

— TRuE  

Official title:

Risk Stratification in Patients With Severe Tricuspid Regurgitation: Insights From the TRicuspid Regurgitation rEgistry (TRuE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04173091
• Other study ID #: TRuE012013
• Status: Recruiting
• Start date: January 1, 2013
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 30, 2023
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Severe functional tricuspid regurgitation

Exclusion Criteria:

prior surgery or congenital heart diseases with involvement of the tricuspid valve

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Diagnostic Test:
• No Intervention
No Intervention planed

Locations

Country	Name	City	State
Germany	Brunilda Alushi	Berlin
Germany	Contilia Heart and Vascular Centre	Essen
Germany	Department of Internal Medicine and Cardiology, Heart Centre Leipzig	Leipzig
Germany	German Heart Centre	Munich
Israel	Rabin Medical Centre	Tel Aviv	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Mortality due to all causes	1 year
Primary	All-cause mortality	Mortality due to all causes	5 years
Primary	All-cause mortality	Mortality due to all causes	10 years
Secondary	Cardiovascular mortality	Mortality due to cardiovascular causes	1 year
Secondary	Cardiovascular mortality	Mortality due to cardiovascular causes	5 years
Secondary	Cardiovascular mortality	Mortality due to cardiovascular causes	10 years
Secondary	Number of hospitalizations	Number of hospitalizations due to right heart failure	1 year
Secondary	Number of hospitalizations	Number of hospitalizations due to right heart failure	2 years
Secondary	Number of hospitalizations	Number of hospitalizations due to right heart failure	5 years
Secondary	Number of hospitalizations	Number of hospitalizations due to right heart failure	10 years