Residual Tricuspid RegurgitationNCT04414358
Incidence of Residual Tricuspid Regurgitation in Patients Undergoing Left-heart Surgery
An observational study of Residual Tricuspid Regurgitation and Left-sided Cardiac Surgery, run by Mahidol University at 1 site in Thailand.
Trial summary
Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Tricuspid Regurgitation, Left-sided Cardiac Surgery
- How many people
- 275 participants
- Where
- 1 siteThailand
- Study dates
- 20 Nov 2020to 30 Apr 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients scheduled for surgery according to the criteria in Siriraj hospital, Mahidol university will be recruited
Who may be able to join
- Mitral valve or aortic valve diseases requiring surgical intervention
- No pathologic changes in TV leaflets
- No previous tricuspid valve surgery
Who cannot join
- Patients with incomplete data
- Patient with history of previous cardiac surgery
- Patient with congenital anomalies of mitral or tricuspid valve
- Patient with both tricuspid stenosis and regurgitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Residual Significant Tricuspid Regurgitation in Patients Undergoing Left-sided Cardiac Surgery
Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. The investigators would like to determine the incidence of significant residual tricuspid regurgitation after left-sided cardiac surgery and related clinical outcome.
Read the detailed description
Functional tricuspid regurgitation (TR) was defined as TR occurring secondary to left heart, especially mitral valve stenosis or pulmonary disease. Previous study reported that about 30% - 50% of patients with significant mitral stenosis developed moderate to severe TR. In the past, corrective TR repair was not always indicated because the concept about TR severity will improve after mitral valve lesion was treated.
Later on, several studies demonstrated that the patients with untreated significant (< moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR repair with left-sided valve surgery did not cause adverse events, but improve clinical outcome and quality of life. The current European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in patients with severe TR undergoing left-sided valve surgery (class I recommendation). In patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery in the setting of tricuspid annular dilatation.
However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual TR may still persist and the residual moderate or severe TR have negative impact to right ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported 12.4% of significant TR after surgery and the associated factors for the repair failure. If this group of patients developed symptom of RV failure or progressive RV dilatation or dysfunction is detected, they possessed very high-risk for re-operation.
Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the result of the TR repair. Due to limitation of TTE operator and machine, time-interval between the latest preoperative TTE result and surgery are varied, so the TR severity may already changed. The postoperative TTE result sometimes comes out late after surgery. Therefore, transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may play role to confirm the severity and provide the instant result of the TV repair to help guide the cardiac surgeon to make a decision whether to re-operate in the same setting to improve the surgical outcome.
Therefore, the investigators would like to determine the incidence of residual significant TR by intraoperative TEE in the patients underwent left-side cardiac surgery and the related clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery
- Residual significant tricuspid regurgitation: more than moderate tricuspid regurgitation after corrective surgery
- Left-sided cardiac surgery: mitral or aortic valve surgery
Measured: during surgery
Secondary outcomes (4)
Number of patients with different severity of tricuspid regurgitation
Compare between preoperative trans- thoracic echocardiography and intraoperative transesophageal echocardiography result (before cardiopulmonary bypass initiation)
Measured: during surgery
Length of stay
Length of hospital and ICU stay
Measured: 7 days after surgery
Number of patients require re-operation
Re-operation for tricuspid regurgitation correction
Measured: 1 year after surgery
Number of patients require re-admission
Re-admission due to cardiac cause: right-sided cardiac failure, pulmonary oedema
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start20 Nov 2020
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Residual Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Retrospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aphichat Suphathamwit, M.D>, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414358
- Sponsor's protocol ID
- 2020-3
- Status last verified
- May 2022
- First submitted
- 31 May 2020
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anyanwu AC, Adams DH. Functional tricuspid regurgitation in mitral valve disease: epidemiology and prognostic implications. Semin Thorac Cardiovasc Surg. 2010 Spring;22(1):69-75. doi: 10.1053/j.semtcvs.2010.05.006.
PubMed 20813320Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2.
PubMed 31805294Calafiore AM, Foschi M, Kheirallah H, Alsaied MM, Alfonso JJ, Tancredi F, Gaudino M, Di Mauro M. Early failure of tricuspid annuloplasty. Should we repair the tricuspid valve at an earlier stage? The role of right ventricle and tricuspid apparatus. J Card Surg. 2019 Jun;34(6):404-411. doi: 10.1111/jocs.14042. Epub 2019 Apr 8.
PubMed 30958905
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Residual Significant Tricuspid Regurgitation in Patients Undergoing Left-sided Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04414358
- Acronym / sponsor ID
- 2020-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 4 Jun 2020 (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.
Functional tricuspid valve regurgitation is commonly co-existed with left-sided cardiac lesion, especially mitral valve stenosis. Both lesion were recommended to surgically fixed at the same setting. Residual tricuspid regurgitation may effects patients' outcome. The investigators would like to determine the incidence of significant residual tricuspid regurgitation after left-sided cardiac surgery and related clinical outcome.
Detailed description
Functional tricuspid regurgitation (TR) was defined as TR occurring secondary to left heart, especially mitral valve stenosis or pulmonary disease. Previous study reported that about 30% - 50% of patients with significant mitral stenosis developed moderate to severe TR. In the past, corrective TR repair was not always indicated because the concept about TR severity will improve after mitral valve lesion was treated.
Later on, several studies demonstrated that the patients with untreated significant (< moderate) TR had worse clinical outcome including mortality. While simultaneous functional TR repair with left-sided valve surgery did not cause adverse events, but improve clinical outcome and quality of life. The current European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) and American Heart Association(AHA)/American College of Cardiology (ACC) guidelines recommend concomitant tricuspid valve (TV) surgery in patients with severe TR undergoing left-sided valve surgery (class I recommendation). In patients with mild to moderate TR, there is a class IIa indication for concomitant TV surgery in the setting of tricuspid annular dilatation.
However, after TV repair, commonly with annuloplasty ring or De Vega annuloplasty, residual TR may still persist and the residual moderate or severe TR have negative impact to right ventricle (RV). It can cause RV dilatation and RV failure(7, 12). Calafiore et al reported 12.4% of significant TR after surgery and the associated factors for the repair failure. If this group of patients developed symptom of RV failure or progressive RV dilatation or dysfunction is detected, they possessed very high-risk for re-operation.
Preoperative transthoracic echocardiography (TTE) is an important tool to classified severity of TR, measured TV annulus, indicate the surgical correction requirement and demonstrate the result of the TR repair. Due to limitation of TTE operator and machine, time-interval between the latest preoperative TTE result and surgery are varied, so the TR severity may already changed. The postoperative TTE result sometimes comes out late after surgery. Therefore, transesophageal echocardiography (TEE), operated by trained cardiac anesthesiologist, may play role to confirm the severity and provide the instant result of the TV repair to help guide the cardiac surgeon to make a decision whether to re-operate in the same setting to improve the surgical outcome.
Therefore, the investigators would like to determine the incidence of residual significant TR by intraoperative TEE in the patients underwent left-side cardiac surgery and the related clinical outcome, including rate of re-admission from cardiac cause and 1- year mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients scheduled for surgery according to the criteria in Siriraj hospital, Mahidol university will be recruited
Key inclusion criteria (3 listed)
- Mitral valve or aortic valve diseases requiring surgical intervention
- No pathologic changes in TV leaflets
- No previous tricuspid valve surgery
Key exclusion criteria (4 listed)
- Patients with incomplete data
- Patient with history of previous cardiac surgery
- Patient with congenital anomalies of mitral or tricuspid valve
- Patient with both tricuspid stenosis and regurgitation
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
Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery
Time frame: during surgery
* Residual significant tricuspid regurgitation: more than moderate tricuspid regurgitation after corrective surgery * Left-sided cardiac surgery: mitral or aortic valve surgery
4 secondary outcomes
Number of patients with different severity of tricuspid regurgitation
Time frame: during surgery
Length of stay
Time frame: 7 days after surgery
Number of patients require re-operation
Time frame: 1 year after surgery
Number of patients require re-admission
Time frame: 1 year after surgery
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 May 2022.
- Background: PubMed 20813320Anyanwu AC, Adams DH. Functional tricuspid regurgitation in mitral valve disease: epidemiology and prognostic implications. Semin Thorac Cardiovasc Surg. 2010 Spring;22(1):69-75. doi: 10.1053/j.semtcvs.2010.05.006.
- Background: PubMed 31805294Hamandi M, George TJ, Smith RL, Mack MJ. Current outcomes of tricuspid valve surgery. Prog Cardiovasc Dis. 2019 Nov-Dec;62(6):463-466. doi: 10.1016/j.pcad.2019.11.014. Epub 2019 Dec 2.
- Background: PubMed 30958905Calafiore AM, Foschi M, Kheirallah H, Alsaied MM, Alfonso JJ, Tancredi F, Gaudino M, Di Mauro M. Early failure of tricuspid annuloplasty. Should we repair the tricuspid valve at an earlier stage? The role of right ventricle and tricuspid apparatus. J Card Surg. 2019 Jun;34(6):404-411. doi: 10.1111/jocs.14042. Epub 2019 Apr 8.
- Individual participant dataSharing planned: No
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.
Aphichat Suphathamwit, M.D> principal investigator
Mahidol University
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 Residual Tricuspid Regurgitation and Left-sided Cardiac Surgery, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 4 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 May 2022. 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 Thailand. 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?
Number of patients with residual significant tricuspid regurgitation after left-sided cardiac surgery (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414358, which also lists 3 linked publications.
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 May 2022.