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

Tracking Information
First Received Date ^ICMJE	September 14, 2010
Last Updated Date	December 11, 2012
Start Date ^ICMJE	January 2009
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 14, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01203137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prognostic Value of Early Postoperative Right Ventricular Systolic Function in Patients With Isolated Severe Tricuspid Regurgitation
Official Title ^ICMJE	Not Provided
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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition ^ICMJE	Tricuspid Regurgitation
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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.
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	Completed
Estimated Enrollment ^ICMJE	60
Completion Date	Not Provided
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: severe tricuspid regurgitation Exclusion Criteria: concomitant left-sided valve surgery significant coronary artery disease
Gender	Both
Ages	21 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01203137
Other Study ID Numbers ^ICMJE	H-1009-014-331
Has Data Monitoring Committee	No
Responsible Party	Hyung-Kwan Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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