Tricuspid RegurgitationNCT01203137
Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
An observational study of Tricuspid Regurgitation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Tricuspid Regurgitation
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Feb 2011
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We prospectively recruited consecutive patients with isolated (without any other valvular dysfunction) severe TR who underwent corrective surgery.
Who may be able to join
- severe tricuspid regurgitation
Who cannot join
- concomitant left-sided valve surgery
- significant coronary artery disease
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.
Read the detailed description
We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.
- Conditions
- Tricuspid Regurgitation
- Keywords
- tricuspid regurgitation, severe
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| tricuspid regurgitation, severe | To be included in the present study, the following 3 criteria for severe TR should be met based on the preoperative echocardiography: (1) TR jet > 30% of right atrial area, (2) inadequate cusp coaptation, and (3) systolic flow reversal in the hepatic vein. |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical event
Clinical events were defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems.
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
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 Seoul National University HospitalThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung-Kwan Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203137
- Sponsor's protocol ID
- H-1009-014-331
- Status last verified
- Dec 2012
- First submitted
- 14 Sep 2010
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT01203137
- Acronym / sponsor ID
- H-1009-014-331
- Conditions
- Tricuspid Regurgitation
- Keywords
- tricuspid regurgitation, severe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- First posted
- 16 Sep 2010 (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.
Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.
Detailed description
We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tricuspid regurgitation, severe | – | –To be included in the present study, the following 3 criteria for severe TR should be met based on the preoperative echocardiography: (1) TR jet > 30% of right atrial area, (2) inadequate cusp coaptation, and (3) systolic flow reversal in the hepatic vein. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We prospectively recruited consecutive patients with isolated (without any other valvular dysfunction) severe TR who underwent corrective surgery.
Key inclusion criteria (1 listed)
- severe tricuspid regurgitation
Key exclusion criteria (2 listed)
- concomitant left-sided valve surgery
- significant coronary artery disease
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
clinical event
Time frame: 40 months
Clinical events were defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems.
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 13 Dec 2012.
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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 Seoul National University Hospital 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 2 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 13 Dec 2012. 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?
clinical event (time frame: 40 months). 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 13 Dec 2012.