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Surgery in Secondary Tricuspid Regurgitation

Surgery of Secondary Tricuspid Regurgitation

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03953755
Acronym
STRONG
Enrollment
150
Registered
2019-05-17
Start date
2019-01-01
Completion date
2027-12-31
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation

Keywords

tricuspid regurgitation, tricuspid surgery, moderate tricispid

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: 1. 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. 2. 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. 3. 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.

Interventions

Tricuspid valve repair

Sponsors

Saint Petersburg State University, Russia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \> 18 years 2. Indication left-side valve surgery

Exclusion criteria

1. Unwillingness to give informed consent and to enter a regular follow-up program. 2. Prior surgical or percutaneous mitral valve intervention 3. Contraindication to cardiopulmonary bypass (CPB) 4. Clinical signs of cardiogenic shock at the time of randomization

Design outcomes

Primary

MeasureTime frameDescription
square of tricuspid regurgitation3 month, 1 year, 3 yearsquare of tricuspid regurgitation
tricuspid regurgitant volume3 month, 1 year, 3 yeartricuspid regurgitant volume
vtricuspid effective regurgitant oriface3 month, 1 year, 3 yeartricuspid effective regurgitant oriface
Difference in end-diastolic dimension3 month, 1 year, 3 yearDifference in end-diastolic dimension of right ventricle between of pre- and post- operation
Difference in tricuspid annular plane systolic excursion3 month, 1 year, 3 yearDifference in TAPSE between of pre- and post- operation
Difference in right atrium volume index3 month, 1 year, 3 yearDifference in right atrium volume index between of pre- and post- operation
Difference in fraction of area contraction of right ventricle3 month, 1 year, 3 yearDifference in fraction of area contraction between pre- and post- operation
Difference in right ventricle global strain rate3 month, 1 year, 3 yearDifference in right ventricle global strain rate between of pre- and post- operation

Secondary

MeasureTime frameDescription
major adverse cardiac events3 month, 1 year, 3 yeardeath, myocardial infarction, new hospital readmission, heart transplant, ventricular assist device implantation, aborted sudden death, pulmonary oedema
rate of all-cause death3 month, 1 year, 3 yearall-cause death

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026