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

Tricuspid Regurgitation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203137
• Other study ID #: H-1009-014-331
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: December 11, 2012
• Start date: January 2009

Study information

• Verified date: December 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• severe tricuspid regurgitation

Exclusion Criteria:

• concomitant left-sided valve surgery

• significant coronary artery disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical event	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.	40 months	Yes