Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation (TRuE)

March 26, 2020 updated by: Alexander Lauten, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Brunilda Alushi
        • Contact:
        • Principal Investigator:
          • Alexander Lauten, MD
        • Principal Investigator:
          • Brunilda Alushi, MD, PhD
      • Essen, Germany
        • Active, not recruiting
        • Contilia Heart and Vascular centre
      • Leipzig, Germany
      • Munich, Germany
        • Recruiting
        • German Heart Centre
        • Contact:
  • Israel
    • Petah Tikva
      • Tel Aviv, Petah Tikva, Israel, 49100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe functional tricuspid regurgitation diagnosed echocardiographically.

Description

Inclusion Criteria:

Severe functional tricuspid regurgitation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 year
Mortality due to all causes
1 year
All-cause mortality
Time Frame: 5 years
Mortality due to all causes
5 years
All-cause mortality
Time Frame: 10 years
Mortality due to all causes
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 1 year
Mortality due to cardiovascular causes
1 year
Cardiovascular mortality
Time Frame: 5 years
Mortality due to cardiovascular causes
5 years
Cardiovascular mortality
Time Frame: 10 years
Mortality due to cardiovascular causes
10 years
Number of hospitalizations
Time Frame: 1 year
Number of hospitalizations due to right heart failure
1 year
Number of hospitalizations
Time Frame: 2 years
Number of hospitalizations due to right heart failure
2 years
Number of hospitalizations
Time Frame: 5 years
Number of hospitalizations due to right heart failure
5 years
Number of hospitalizations
Time Frame: 10 years
Number of hospitalizations due to right heart failure
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2017

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

November 16, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRuE012013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Tricuspid Regurgitation

Clinical Trials on No Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe