NCT03953755

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jan 2019Dec 2027

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

6 years

First QC Date

May 4, 2019

Last Update Submit

October 18, 2022

Conditions

Tricuspid Regurgitation

Keywords

tricuspid regurgitationtricuspid surgerymoderate tricispid

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (2)

  • major adverse cardiac events

    3 month, 1 year, 3 year

  • rate of all-cause death

    3 month, 1 year, 3 year

Study Arms (4)

Control 1

NO INTERVENTION

no/mild tricuspid regurgitation - left-side surgery alone

moderate TR - left-side surgery

NO INTERVENTION

moderate tricuspid regurgitation - left-side surgery alone

moderate TR - left-side surgery+TVS

EXPERIMENTAL

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

Procedure: Tricuspid valve repair

Control 2

NO INTERVENTION

tricuspid regurgitation - left-side surgery +tricuspid valve surgery

Interventions

Tricuspid valve repairPROCEDURE

Tricuspid valve repair

moderate TR - left-side surgery+TVS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Indication left-side valve surgery

You may not qualify if:

  • Unwillingness to give informed consent and to enter a regular follow-up program.
  • Prior surgical or percutaneous mitral valve intervention
  • Contraindication to cardiopulmonary bypass (CPB)
  • Clinical signs of cardiogenic shock at the time of randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Petersburg State University

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Dmitry Shmatov, MD, PhD

    Saint Petersburg State University, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director for scince

Study Record Dates

First Submitted

May 4, 2019

First Posted

May 17, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

October 20, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Study protocol

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
3 year

Locations

RU(1)