PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients

Completed

• Conditions: Right Heart Failure; Right Ventricular Dysfunction; Right Ventricular Failure; Mitral Valve Disease

• Registration Number: NCT03438825
• Lead Sponsor: Semmelweis University Heart and Vascular Center

Brief Summary

The PREPARE-MVR (PRediction of Early PostoperAtive Right vEntricular failure in Mitral Valve Replacement/Repair patients) Study aims to evaluate those preoperative factors which can predict the early postoperative right ventricular failure or determine the functional shift seen in right ventricular function after mitral valve replacement/repair. The PREPARE-MVR study focuses mainly on echocardiographic (both conventional and advanced) parameters and includes right heart catheterization intraoperatively and in the early postoperative period as gold standard method.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2018-02-11
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-20
• Primary Completion: 2018-11
• Status Verified: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• patients admitted for mitral valve replacement/repair
• severe mitral valve insufficiency

Exclusion Criteria

• preoperative right ventricular dysfunction
• cardiac surgery in medical history
• infective endocarditis
• primary cardiomyopathies
• congenital heart disease
• decreased left ventricular ejection fraction
• pulmonary embolism in medical history
• severe chronic obstructive pulmonary disease
• primary pulmonary hypertension
• any malignancy affecting right heart

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
right ventricular failure	From date of operation until the date of first documented right ventricular failure assessed up to 6 months	Early postoperative right ventricular failure is defined as right ventricular stroke work index \<300 mmHg/mL/m2 measured by right heart catheterization. Late right ventricular failure is defined as \>10% decrease in right ventricular ejection fraction compared to preoperative value measured by 3D echocardiography.

Trial Locations

Locations (1)

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary