Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgery in Secondary Tricuspid Regurgitation (STRONG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Procedure: Tricuspid valve repair Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgery of Secondary Tricuspid Regurgitation
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2027

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



Primary Outcome Measures :
  1. 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

  2. Difference in tricuspid annular plane systolic excursion [ Time Frame: 3 month, 1 year, 3 year ]
    Difference in TAPSE between of pre- and post- operation

  3. 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

  4. 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

  5. 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

  6. tricuspid regurgitant volume [ Time Frame: 3 month, 1 year, 3 year ]
    tricuspid regurgitant volume

  7. vtricuspid effective regurgitant oriface [ Time Frame: 3 month, 1 year, 3 year ]
    tricuspid effective regurgitant oriface

  8. square of tricuspid regurgitation [ Time Frame: 3 month, 1 year, 3 year ]
    square of tricuspid regurgitation


Secondary Outcome Measures :
  1. 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

  2. rate of all-cause death [ Time Frame: 3 month, 1 year, 3 year ]
    all-cause death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953755


Contacts
Layout table for location contacts
Contact: Angela Zagatina, MD, PhD +79213297087 zag_angel@yahoo.com
Contact: Dmitry Shmatov, MD, PhD +79110833115 dv.shmatov@gmail.com

Locations
Layout table for location information
Russian Federation
St. Petersburg State University Recruiting
Saint Petersburg, Russian Federation, 190103
Contact: Angela Zagatina, MD, PhD    +79213297087    zag_angel@yahoo.com   
Sponsors and Collaborators
Saint Petersburg State University, Russia
Investigators
Layout table for investigator information
Principal Investigator: Dmitry Shmatov, MD, PhD Saint Petersburg State University, Russia
  Study Documents (Full-Text)

Documents provided by Zagatina Angela, Saint Petersburg State University, Russia:
Informed Consent Form  [PDF] June 6, 2018


Layout table for additonal information
Responsible Party: Zagatina Angela, Head of cardiology department, Saint Petersburg State University, Russia
ClinicalTrials.gov Identifier: NCT03953755     History of Changes
Other Study ID Numbers: 5/2018
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study protocol
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 3 year

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zagatina Angela, Saint Petersburg State University, Russia:
tricuspid regurgitation
tricuspid surgery
moderate tricispid
Additional relevant MeSH terms:
Layout table for MeSH terms
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases