Tricuspid RegurgitationNCT06926959
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
An observational study of Tricuspid Regurgitation, run by Sun Yat-sen University at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- How many people
- 3,000 participants
- Where
- 7 sitesChina
- Study dates
- 15 Jun 2016to 15 Jun 2030
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients diagnosed with tricuspid regurgitation (TR) during hospitalization were enrolled.
Who may be able to join
- Aged over 18 yrs.
- Patients diagnosed with tricuspid regurgitation during hospitalization.
Who cannot join
- Patients unable to provide informed consent.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen Univerity
Guangzhou, Guangdong, 510000
Xiaodong Zhuang, +8613760755035, zhuangxd3@mail.sysu.edu.cn
- Active, not recruiting
Third Affiliated Hospital, Sun Yat-Sun University,
Guangzhou, Guangdong, 510000
- Active, not recruiting
Jieyang People's Hospital
Jieyang, Guangdong, 522000
- Active, not recruiting
Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
- Active, not recruiting
Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, 518000
- Active, not recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
- Active, not recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528400
About this study
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.
- Conditions
- Tricuspid Regurgitation
- Keywords
- Tricuspid Regurgitation, all-cause mortality, risk factor, prediction model
- Medical subject headings
- Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Death due to any cause after enrollment
Measured: Through study completion, an average of 5 years
Secondary outcomes (2)
Cardiovascular death
Death caused by cardiac causes
Measured: 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.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Jun 2016
- Primary completion15 Jun 2030 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, Second Affiliated Hospital of Shantou University Medical College, Eighth Affiliated Hospital, Sun Yat-sen University, Zhongshan People's Hospital, Guangdong, China, Jieyang People's Hospital
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926959
- Sponsor's protocol ID
- TRAIL study
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
- ClinicalTrials.gov ID
- NCT06926959
- Acronym / sponsor ID
- TRAIL study
- Conditions
- Tricuspid Regurgitation
- Keywords
- Tricuspid Regurgitation, all-cause mortality, risk factor, prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, Second Affiliated Hospital of Shantou University Medical College, Eighth Affiliated Hospital, Sun Yat-sen University, Zhongshan People's Hospital, Guangdong, China, Jieyang People's Hospital
- Study start
- 15 Jun 2016 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with tricuspid regurgitation (TR) during hospitalization were enrolled.
Key inclusion criteria (2 listed)
- Aged over 18 yrs.
- Patients diagnosed with tricuspid regurgitation during hospitalization.
Key exclusion criteria (1 listed)
- Patients unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: Through study completion, an average of 5 years
Death due to any cause after enrollment
2 secondary outcomes
Cardiovascular death
Time frame: Through study completion, an average of 5 years
Heart Failure Hospitalization
Time frame: Through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
Related trials for Tricuspid Regurgitation
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Not yet recruiting
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
Tricuspid Valve Disease, Heart Valve Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by Sun Yat-sen University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Zhuang (+8613760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.