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Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01203137
Collaborator
(none)
60
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Preoperative right ventricular end-systolic area (RV-ESA) and hemoglobin level were suggested as independent prognosticator for predicting long-term prognosis in patients with isolated severe TR undergoing corrective surgery We attempted to explore whether early postoperative echocardiography provides additional prognostic information on top of preoperative clinical and echocardiographic variables.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We prospectively recruited patients with isolated severe TR undergoing corrective surgery. Comprehensive preoperative echocardiography was performed in all patients, with the performance of early postoperative echocardiography in all patients. During follow-up, clinical events, defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems were investigated.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Feb 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    tricuspid regurgitation, severe

    To be included in the present study, the following 3 criteria for severe TR should be met based on the preoperative echocardiography: (1) TR jet > 30% of right atrial area, (2) inadequate cusp coaptation, and (3) systolic flow reversal in the hepatic vein.

    Outcome Measures

    Primary Outcome Measures

    1. clinical event [40 months]

      Clinical events were defined as operative mortality (death within 30 days after surgery or before discharge), cardiovascular death, repeated open heart surgery, and readmission due to cardiovascular problems.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • severe tricuspid regurgitation
    Exclusion Criteria:

    • concomitant left-sided valve surgery

    • significant coronary artery disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyung-Kwan Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01203137
    Other Study ID Numbers:
    • H-1009-014-331
    First Posted:
    Sep 16, 2010
    Last Update Posted:
    Dec 13, 2012
    Last Verified:
    Dec 1, 2012
    Keywords provided by Hyung-Kwan Kim, Professor, Seoul National University Hospital
    tricuspid regurgitation, severe
    Additional relevant MeSH terms:
    Tricuspid Valve Insufficiency

    Study Results

    No Results Posted as of Dec 13, 2012