Tricuspid RegurgitationNCT01502462
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
An observational study of Tricuspid Regurgitation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases. Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Tricuspid Regurgitation
- How many people
- 131 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2012to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases. Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR
Who may be able to join
- Severe isolated TR for more than 6 months
Who cannot join
- Severe mitral and aortic valvular heart disease
- Age equals to or more than 75 years
- Malignancy or serious comorbidity with life expectancy < 5years
- Acute or subacute infective endocarditis requiring antibiotics therapy
- Untreated hyperthyroidism
- Constrictive pericarditis
Show all 12Show fewer
- Unclosed significant atrial septal defect
- Previous tricuspid valve surgery
- Significant coronary artery disease
- Cardiomyopathy
- Pregnancy
- Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
Trial locations and contacts
1 site in 1 country.
About this study
Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.
Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.
Read the detailed description
Inclusion criteria Severe isolated TR for more than 6 months
Exclusion criteria
- Severe mitral and aortic valvular heart disease
- Age equals to or more than 75 years
- Malignancy or serious comorbidity with life expectancy < 5years
- Acute or subacute infective endocarditis requiring antibiotics therapy
- Untreated hyperthyroidism
- Constrictive pericarditis
- Unclosed significant atrial septal defect
- Previous tricuspid valve surgery
- Significant coronary artery disease
- Cardiomyopathy
- Pregnancy
- Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
- Conditions
- Tricuspid Regurgitation
- Keywords
- Clinical course and prognostic factors in patients with severe isolated TR
- Medical subject headings
- Tricuspid Valve Insufficiency, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause death
Measured: 5 years
Secondary outcomes (3)
Hospitalization of cardiovascular causes
Measured: 5 years
tricuspid valve surgery
Measured: 5 years
stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
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 Asan Medical CenterThe 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
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Min Song, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502462
- Sponsor's protocol ID
- Severe_Isol_TR
- Status last verified
- Feb 2021
- First submitted
- 29 Dec 2011
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT01502462
- Acronym / sponsor ID
- Severe_Isol_TR
- Conditions
- Tricuspid Regurgitation
- Keywords
- Clinical course and prognostic factors in patients with severe isolated TR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 30 Dec 2011 (estimated)
- 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.
Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.
Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.
Detailed description
Inclusion criteria Severe isolated TR for more than 6 months
Exclusion criteria
- Severe mitral and aortic valvular heart disease
- Age equals to or more than 75 years
- Malignancy or serious comorbidity with life expectancy < 5years
- Acute or subacute infective endocarditis requiring antibiotics therapy
- Untreated hyperthyroidism
- Constrictive pericarditis
- Unclosed significant atrial septal defect
- Previous tricuspid valve surgery
- Significant coronary artery disease
- Cardiomyopathy
- Pregnancy
- Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases. Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR
Key inclusion criteria (1 listed)
- Severe isolated TR for more than 6 months
Key exclusion criteria (12 listed)
- Severe mitral and aortic valvular heart disease
- Age equals to or more than 75 years
- Malignancy or serious comorbidity with life expectancy < 5years
- Acute or subacute infective endocarditis requiring antibiotics therapy
- Untreated hyperthyroidism
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 death
Time frame: 5 years
3 secondary outcomes
Hospitalization of cardiovascular causes
Time frame: 5 years
tricuspid valve surgery
Time frame: 5 years
stroke
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Asan Medical Center at 1 site in South Korea.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause death (time frame: 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 2 Feb 2021.