Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study) | NCT06926959

Studies
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)

NCT06926959

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Apr 15, 2025Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Tricuspid Regurgitation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2016Actual

Primary Completion Date

Jun 15, 2030Estimated

Completion Date

Jun 15, 2030Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Apr 11, 2025

First Posted Date

Apr 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2025

Last Update Posted Date

Apr 15, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao-dong Zhuang, Professor, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Name	Class
First Affiliated Hospital, Sun Yat-Sen University	OTHER
Third Affiliated Hospital, Sun Yat-Sen University	OTHER
Affiliated Hospital of Guangdong Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

15 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients unable to provide informed consent.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaodong Zhuang	Contact	+8613760755035		zhuangxd3@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Sun Yat-sen Univerity	Recruiting	Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided