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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hyung-Kwan Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01203137
First received: September 14, 2010
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Tricuspid Regurgitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • clinical event [ Time Frame: 40 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 60
Study Start Date: January 2009
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We prospectively recruited consecutive patients with isolated (without any other valvular dysfunction) severe TR who underwent corrective surgery.

Criteria

Inclusion Criteria:

  • severe tricuspid regurgitation

Exclusion Criteria:

  • concomitant left-sided valve surgery
  • significant coronary artery disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203137

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyung-Kwan Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01203137     History of Changes
Other Study ID Numbers: H-1009-014-331
Study First Received: September 14, 2010
Last Updated: December 11, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
tricuspid regurgitation, severe

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013