Clinical trial NCT03953755: Surgery in Secondary Tricuspid Regurgitation
Official title: Surgery of Secondary Tricuspid Regurgitation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Tricuspid Regurgitation
Keywords: tricuspid regurgitation
tricuspid surgery
moderate tricispid
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in end-diastolic dimension
timeFrame: 3 month, 1 year, 3 year
measure: Difference in tricuspid annular plane systolic excursion
timeFrame: 3 month, 1 year, 3 year
measure: Difference in right atrium volume index
timeFrame: 3 month, 1 year, 3 year
measure: Difference in fraction of area contraction of right ventricle
timeFrame: 3 month, 1 year, 3 year
measure: Difference in right ventricle global strain rate
timeFrame: 3 month, 1 year, 3 year
measure: tricuspid regurgitant volume
timeFrame: 3 month, 1 year, 3 year
measure: vtricuspid effective regurgitant oriface
timeFrame: 3 month, 1 year, 3 year
measure: square of tricuspid regurgitation
timeFrame: 3 month, 1 year, 3 year
Secondary outcomes:
measure: major adverse cardiac events
timeFrame: 3 month, 1 year, 3 year
measure: rate of all-cause death
timeFrame: 3 month, 1 year, 3 year
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State University
Study officials:
affiliation: Saint Petersburg State University, Russia
name: Dmitry Shmatov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: