Surgery in Secondary Tricuspid Regurgitation (STRONG)

Surgery of Secondary Tricuspid Regurgitation

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.

Study Overview

• Status: Suspended
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Procedure: Tricuspid valve repair

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 190103
    • St. Petersburg State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in end-diastolic dimension	Difference in end-diastolic dimension of right ventricle between of pre- and post- operation	3 month, 1 year, 3 year
Difference in tricuspid annular plane systolic excursion	Difference in TAPSE between of pre- and post- operation	3 month, 1 year, 3 year
Difference in right atrium volume index	Difference in right atrium volume index between of pre- and post- operation	3 month, 1 year, 3 year
Difference in fraction of area contraction of right ventricle	Difference in fraction of area contraction between pre- and post- operation	3 month, 1 year, 3 year
Difference in right ventricle global strain rate	Difference in right ventricle global strain rate between of pre- and post- operation	3 month, 1 year, 3 year
tricuspid regurgitant volume	tricuspid regurgitant volume	3 month, 1 year, 3 year
vtricuspid effective regurgitant oriface	tricuspid effective regurgitant oriface	3 month, 1 year, 3 year
square of tricuspid regurgitation	square of tricuspid regurgitation	3 month, 1 year, 3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiac events	death, myocardial infarction, new hospital readmission, heart transplant, ventricular assist device implantation, aborted sudden death, pulmonary oedema	3 month, 1 year, 3 year
rate of all-cause death	all-cause death	3 month, 1 year, 3 year

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia
• Investigators: Principal Investigator: Dmitry Shmatov, MD, PhD, Saint Petersburg State University, Russia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: May 4, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: tricuspid regurgitation; tricuspid surgery; moderate tricispid
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 5/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol
• IPD Sharing Time Frame: 3 year
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No