Surgery in Secondary Tricuspid Regurgitation

NCT ID: NCT03953755

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2027-12-31

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.

Conditions

Tricuspid Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control 1

no/mild tricuspid regurgitation - left-side surgery alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

moderate TR - left-side surgery

moderate tricuspid regurgitation - left-side surgery alone

Group Type: NO_INTERVENTION

No interventions assigned to this group

moderate TR - left-side surgery+TVS

moderate tricuspid regurgitation - left-side surgery+tricuspid valve surgery

Group Type: EXPERIMENTAL

Tricuspid valve repair

Intervention Type: PROCEDURE

Tricuspid valve repair

Control 2

tricuspid regurgitation - left-side surgery +tricuspid valve surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tricuspid valve repair

Tricuspid valve repair

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: lead

Responsible Party

Efremov Sergey

Deputy director for scince

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dmitry Shmatov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg State University, Russia

Locations

St. Petersburg State University

Saint Petersburg, , Russia

Countries

Russia

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

5/2018

Identifier Type: -

Identifier Source: org_study_id