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Clinical Trials/NCT03438825
NCT03438825
Completed
Not Applicable

The PREPARE-MVR Study: PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients

Semmelweis University Heart and Vascular Center1 site in 1 country72 target enrollmentOctober 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Right Heart Failure
Sponsor
Semmelweis University Heart and Vascular Center
Enrollment
72
Locations
1
Primary Endpoint
right ventricular failure
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
April 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Semmelweis University Heart and Vascular Center
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

right ventricular failure

Time Frame: 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.

Study Sites (1)

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