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

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ClinicalTrials.gov Identifier: NCT03438825
Recruitment Status : Recruiting
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Right Heart Failure Right Ventricular Dysfunction Right Ventricular Failure Mitral Valve Disease Procedure: Mitral valve replacement/repair

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The PREPARE-MVR Study: PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

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


Primary Outcome Measures :
  1. right ventricular failure [ Time Frame: From date of operation until the date of first documented right ventricular failure assessed up to 12 months ]
    postoperative right ventricular failure defined as significant decrease in cardiac index, need for inotropic support, prolonged ICU stay or other relevant forms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with isolated severe mitral valve insufficiency admitted for replacement/repair surgery as described in inclusion, exclusion criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438825


Contacts
Contact: Attila Kovács, MD, PhD +36206663427 kovatti@gmail.com

Locations
Hungary
Semmelweis University Heart and Vascular Center Recruiting
Budapest, Hungary, 1122
Contact: Attila Kovács, MD, PhD         
Sponsors and Collaborators
Semmelweis University Heart and Vascular Center

Responsible Party: Semmelweis University Heart and Vascular Center
ClinicalTrials.gov Identifier: NCT03438825     History of Changes
Other Study ID Numbers: PREPARE-MVR1.0
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Right
Heart Diseases
Cardiovascular Diseases