PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients (PREPARE-MVR)

April 2, 2019 updated by: Semmelweis University Heart and Vascular Center

The PREPARE-MVR Study: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Semmelweis University Heart and Vascular Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with isolated severe mitral valve insufficiency admitted for replacement/repair surgery as described in inclusion, exclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of operation until the date of first documented right ventricular failure assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University Heart and Vascular Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

November 1, 2018

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

February 11, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (ACTUAL)

February 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREPARE-MVR1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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