Surgery in Secondary Tricuspid Regurgitation (STRONG)
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|ClinicalTrials.gov Identifier: NCT03953755|
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tricuspid Regurgitation||Procedure: Tricuspid valve repair||Not Applicable|
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Background It has been demonstrated in recent large patient monitoring registers that the presence of even mild secondary tricuspid regurgitation (TR) has a significant effect on life expectancy. Currently, in cardiology/cardiosurgery the indicators for the surgical correction of secondary TR are unclear. In this area, international guidelines lack randomized studies and are based on a C level of evidence. C level evidence is based solely on the opinion of experts, retrospective, and/or observational studies. The first indicator for tricuspid valve (TV) surgery is considered to be a combination of TR with severe aortic or mitral valve lesions that require surgical treatment. However, the level of indicators for moderate corrections in such situations is typically II A-B. At the C level of evidence there is no consensus for surgical treatment of such a defect in the international community. Severe TR indicators are Class I while the evidence remains C level because it is not well established that surgical treatment improves the prognosis of these patients. There is a lack of information about the structural and functional changes of the right ventricle after surgery depending on the degree of TR.
Aims and objectives of studying AIM: To compare right ventricle structural and functional changes after operation in patients with secondary tricuspid regurgitation with severe mitral /aortic valve pathology, requiring surgical intervention; define the factors influencing major adverse cardiac events depending on the operation/non-operation due to moderate tricuspid regurgitation.
- To study tricuspid regurgitation parameters affecting the long-term prognosis for the surgical correction of severe secondary tricuspid regurgitationof patients with severe aortic/mitral valve pathology requiring surgical treatment.
- To define hemodynamic parameters of patients with moderate tricuspid regurgitation, when surgical treatment of this defect gives an additional improvement in the short-term and long-term prognosis following surgical treatment of severe aortic/mitral valve diseases.
- To study changes in contractility parameters in the right ventricle and tricuspid valve function after reconstructive surgery over a period of 3 years.
Methods and study plans This study intends to include 200-300 people and will occur over 5 years with an additional 3-year follow-up.
Inclusion criterion: 1) Signed informed consent form, 2) Previously diagnosed aortic or mitral heart diseases requiring surgical treatment, 3) Over 18 years of age 4) The presence of moderate or severe secondary tricuspid insufficiency.
Exclusion criterion: 1) Significant oncology diseases with a known prognosis of a less than 1 year life expectancy.
Cardiologist examination and survey. Echocardiography All patients will undergo standard echocardiography, including a detailed study of the function and sizes of the right ventricle and right atrium, and measurement of global longitudinal left ventricular deformations using the Speckle Tracking method, peak systolic and diastolic blood flow velocity in TV, fractional changes in area, and tricuspid annulus systolic excursion. Tricuspid regurgitation will be measured according to the standards of EAE/ASE, and will also use the recent 3-tiered classification system of severe insufficiency.
Laboratory techniques Standard for surgical treatment of aortic/mitral valve Coronary catheterization Standard for surgical treatment of aortic/mitral valve, Plan I. Initial visit - cardiologist/cardiosurgeon clinical evaluation - survey and examination II. Echocardiography study - screening - defining degree of tricuspid regurgitation III. Common tests for surgical treatment of aortic/mitral valve IV. Patient randomization with only a moderate degree of TR V. Surgical treatment VI. 30-40 days after surgery - cardiologist examination VII. 90 days after surgery ¬ - cardiologist examination + echocardiography VIII. 1 year after surgery - cardiologist examination + echocardiography IX. 3 years after surgery - cardiologist examination + echocardiography Expected benefits for patients All patients will receive advanced tests using the latest safe ultrasound methods. Frequent echocardiography and patient observations can reveal possible complications after cardiac surgery for aortic/mitral diseases; This study will allow for the correction of drug therapy due to extended diagnosis.
Severe lesions of the tricuspid valve and aortic / mitral heart defects will be corrected in all patients.
New and / or untested methods of treatment will not be used in this study. All surgical procedures will already have undergone testing and been proven effective for the treatment of heart diseases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgery of Secondary Tricuspid Regurgitation|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2027|
No Intervention: Control 1
no/mild tricuspid regurgitation - left-side surgery alone
No Intervention: moderate TR - left-side surgery
moderate tricuspid regurgitation - left-side surgery alone
Experimental: moderate TR - left-side surgery+TVS
moderate tricuspid regurgitation - left-side surgery+tricuspid valve surgery
Procedure: Tricuspid valve repair
Tricuspid valve repair
No Intervention: Control 2
tricuspid regurgitation - left-side surgery +tricuspid valve surgery
- Difference in end-diastolic dimension [ Time Frame: 3 month, 1 year, 3 year ]Difference in end-diastolic dimension of right ventricle between of pre- and post- operation
- Difference in tricuspid annular plane systolic excursion [ Time Frame: 3 month, 1 year, 3 year ]Difference in TAPSE between of pre- and post- operation
- Difference in right atrium volume index [ Time Frame: 3 month, 1 year, 3 year ]Difference in right atrium volume index between of pre- and post- operation
- Difference in fraction of area contraction of right ventricle [ Time Frame: 3 month, 1 year, 3 year ]Difference in fraction of area contraction between pre- and post- operation
- Difference in right ventricle global strain rate [ Time Frame: 3 month, 1 year, 3 year ]Difference in right ventricle global strain rate between of pre- and post- operation
- tricuspid regurgitant volume [ Time Frame: 3 month, 1 year, 3 year ]tricuspid regurgitant volume
- vtricuspid effective regurgitant oriface [ Time Frame: 3 month, 1 year, 3 year ]tricuspid effective regurgitant oriface
- square of tricuspid regurgitation [ Time Frame: 3 month, 1 year, 3 year ]square of tricuspid regurgitation
- major adverse cardiac events [ Time Frame: 3 month, 1 year, 3 year ]death, myocardial infarction, new hospital readmission, heart transplant, ventricular assist device implantation, aborted sudden death, pulmonary oedema
- rate of all-cause death [ Time Frame: 3 month, 1 year, 3 year ]all-cause death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953755
|Contact: Angela Zagatina, MD, PhDfirstname.lastname@example.org|
|Contact: Dmitry Shmatov, MD, PhDemail@example.com|
|St. Petersburg State University||Recruiting|
|Saint Petersburg, Russian Federation, 190103|
|Contact: Angela Zagatina, MD, PhD +79213297087 firstname.lastname@example.org|
|Principal Investigator:||Dmitry Shmatov, MD, PhD||Saint Petersburg State University, Russia|