Condition or disease | Intervention/treatment | Phase |
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Tricuspid Regurgitation | Procedure: Tricuspid valve repair | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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No Intervention: Control 1
no/mild tricuspid regurgitation - left-side surgery alone
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No Intervention: moderate TR - left-side surgery
moderate tricuspid regurgitation - left-side surgery alone
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Experimental: moderate TR - left-side surgery+TVS
moderate tricuspid regurgitation - left-side surgery+tricuspid valve surgery
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Procedure: Tricuspid valve repair
Tricuspid valve repair
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No Intervention: Control 2
tricuspid regurgitation - left-side surgery +tricuspid valve surgery
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angela Zagatina, MD, PhD | +79213297087 | zag_angel@yahoo.com | |
Contact: Dmitry Shmatov, MD, PhD | +79110833115 | dv.shmatov@gmail.com |
Russian Federation | |
St. Petersburg State University | Recruiting |
Saint Petersburg, Russian Federation, 190103 | |
Contact: Angela Zagatina, MD, PhD +79213297087 zag_angel@yahoo.com |
Principal Investigator: | Dmitry Shmatov, MD, PhD | Saint Petersburg State University, Russia |
Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | May 4, 2019 | ||||||||||||||
First Posted Date ICMJE | May 17, 2019 | ||||||||||||||
Last Update Posted Date | September 25, 2020 | ||||||||||||||
Actual Study Start Date ICMJE | January 1, 2019 | ||||||||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | Surgery in Secondary Tricuspid Regurgitation | ||||||||||||||
Official Title ICMJE | Surgery of Secondary Tricuspid Regurgitation | ||||||||||||||
Brief Summary | Currently, in cardiology/cardiosurgery the indicators for the surgical correction of secondary tricuspid regurgitationare unclear. 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. This study intends to include 200-300 people and will occur over 5 years with an additional 3-year follow-up. | ||||||||||||||
Detailed Description |
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. OBJECTIVES:
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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Tricuspid Regurgitation | ||||||||||||||
Intervention ICMJE | Procedure: Tricuspid valve repair
Tricuspid valve repair
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
150 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | December 31, 2027 | ||||||||||||||
Estimated Primary Completion Date | December 31, 2024 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Russian Federation | ||||||||||||||
Removed Location Countries | |||||||||||||||
Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT03953755 | ||||||||||||||
Other Study ID Numbers ICMJE | 5/2018 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Zagatina Angela, Saint Petersburg State University, Russia | ||||||||||||||
Study Sponsor ICMJE | Saint Petersburg State University, Russia | ||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||
Investigators ICMJE |
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PRS Account | Saint Petersburg State University, Russia | ||||||||||||||
Verification Date | May 2020 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |