Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)

April 11, 2025 updated by: Xiao-dong Zhuang, Sun Yat-sen University
This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events. The prognostic risk factors of patients with tricuspid regurgitation are evaluated, and the prognostic models are constructed through the follow-up observation.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen Univerity
        • Contact:
      • Guangzhou, Guangdong, China, 510000
        • Active, not recruiting
        • Third Affiliated Hospital, Sun Yat-Sun University,
      • Jieyang, Guangdong, China, 522000
        • Active, not recruiting
        • Jieyang People's Hospital
      • Shantou, Guangdong, China, 515041
        • Active, not recruiting
        • Second Affiliated Hospital of Shantou University Medical College
      • Shenzhen, Guangdong, China, 518000
        • Active, not recruiting
        • Eighth Affiliated Hospital, Sun Yat-sen University
      • Zhanjiang, Guangdong, China, 524001
        • Active, not recruiting
        • Affiliated Hospital of Guangdong Medical University
      • Zhongshan, Guangdong, China, 528400
        • Active, not recruiting
        • Zhongshan People's Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with tricuspid regurgitation (TR) during hospitalization were enrolled.

Description

Inclusion Criteria:

  • Aged over 18 yrs.
  • Patients diagnosed with tricuspid regurgitation during hospitalization.

Exclusion Criteria:

  • Patients unable to provide informed consent.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: Through study completion, an average of 5 years
Death due to any cause after enrollment
Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular death
Time Frame: Through study completion, an average of 5 years
Death caused by cardiac causes
Through study completion, an average of 5 years
Heart Failure Hospitalization
Time Frame: Through study completion, an average of 5 years
Hospitalization with the primary reason for admission as acute decompensated HF and administration of intravenous or mechanical heart failure therapies.
Through study completion, an average of 5 years

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Collaborators

First Affiliated Hospital, Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Zhongshan People's Hospital, Guangdong, China
Jieyang People's Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Second Affiliated Hospital of Shantou University Medical College
Affiliated Hospital of Guangdong Medical University

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)

June 15, 2016

Primary Completion (Estimated)

June 15, 2030

Study Completion (Estimated)

June 15, 2030

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAIL study

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.

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