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Surgery in Secondary Tricuspid Regurgitation (STRONG)

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ClinicalTrials.gov Identifier: NCT03953755
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zagatina Angela, Saint Petersburg State University, Russia

Tracking Information
First Submitted Date  ICMJE May 4, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
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
 (submitted: May 14, 2019)
  • Difference in end-diastolic dimension [ Time Frame: 3 month, 1 year, 3 year ]
    Difference in end-diastolic dimension of right ventricle between of pre- and post- operation
  • Difference in tricuspid annular plane systolic excursion [ Time Frame: 3 month, 1 year, 3 year ]
    Difference in TAPSE between of pre- and post- operation
  • Difference in right atrium volume index [ Time Frame: 3 month, 1 year, 3 year ]
    Difference in right atrium volume index between of pre- and post- operation
  • Difference in fraction of area contraction of right ventricle [ Time Frame: 3 month, 1 year, 3 year ]
    Difference in fraction of area contraction between pre- and post- operation
  • Difference in right ventricle global strain rate [ Time Frame: 3 month, 1 year, 3 year ]
    Difference in right ventricle global strain rate between of pre- and post- operation
  • tricuspid regurgitant volume [ Time Frame: 3 month, 1 year, 3 year ]
    tricuspid regurgitant volume
  • vtricuspid effective regurgitant oriface [ Time Frame: 3 month, 1 year, 3 year ]
    tricuspid effective regurgitant oriface
  • square of tricuspid regurgitation [ Time Frame: 3 month, 1 year, 3 year ]
    square of tricuspid regurgitation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • major adverse cardiac events [ Time Frame: 3 month, 1 year, 3 year ]
    death, myocardial infarction, new hospital readmission, heart transplant, ventricular assist device implantation, aborted sudden death, pulmonary oedema
  • rate of all-cause death [ Time Frame: 3 month, 1 year, 3 year ]
    all-cause death
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tricuspid Regurgitation
Intervention  ICMJE Procedure: Tricuspid valve repair
Tricuspid valve repair
Study Arms  ICMJE
  • 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
    Intervention: Procedure: Tricuspid valve repair
  • No Intervention: Control 2
    tricuspid regurgitation - left-side surgery +tricuspid valve surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
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:

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angela Zagatina, MD, PhD +79213297087 zag_angel@yahoo.com
Contact: Dmitry Shmatov, MD, PhD +79110833115 dv.shmatov@gmail.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Study protocol
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 3 year
Responsible Party Zagatina Angela, Saint Petersburg State University, Russia
Study Sponsor  ICMJE Saint Petersburg State University, Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dmitry Shmatov, MD, PhD Saint Petersburg State University, Russia
PRS Account Saint Petersburg State University, Russia
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP