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

NCT ID: NCT03438825

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mitral valve replacement/repair

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Semmelweis University Heart and Vascular Center

Budapest, , Hungary

Site Status

Countries

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Hungary

References

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Tokodi M, Nemeth E, Lakatos BK, Kispal E, Toser Z, Staub L, Racz K, Soltesz A, Szigeti S, Varga T, Gal J, Merkely B, Kovacs A. Right ventricular mechanical pattern in patients undergoing mitral valve surgery: a predictor of post-operative dysfunction? ESC Heart Fail. 2020 Jun;7(3):1246-1256. doi: 10.1002/ehf2.12682. Epub 2020 Mar 26.

Reference Type DERIVED
PMID: 32220010 (View on PubMed)

Other Identifiers

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PREPARE-MVR1.0

Identifier Type: -

Identifier Source: org_study_id

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