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

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.

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Key information

Conditions

Right Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Mitral Valve Disease Right Ventricular Dysfunction Right Ventricular Failure Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mitral valve replacement/repair

Procedure

Mitral valve replacement/repair: standard of care operation of the mitral valve due to severe insufficiency

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.

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Registry information

Official study title

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

Acronym: PREPARE-MVR

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Feb 20, 2018
Registry last updated: Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed