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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03438825

Acronym

PREPARE-MVR

Enrollment

Registered

2018-02-20

Start date

2016-10-31

Completion date

2019-04-30

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREMitral valve replacement/repair

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026