ClinicalTrials.gg
CompletedNCT03438825PREPARE-MVRUpdated Apr 4, 2019

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

An observational study in Right Heart Failure, Right Ventricular Dysfunction and Right Ventricular Failure, sponsored by Semmelweis University Heart and Vascular Center. Completed at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by Semmelweis University Heart and Vascular Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
72
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Right Heart Failure
  • Right Ventricular Dysfunction
  • Right Ventricular Failure
  • Mitral Valve Disease
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In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 72 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Semmelweis University Heart and Vascular Center is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients admitted for mitral valve replacement/repair
  • severe mitral valve insufficiency

Exclusion criteria

Exclusion Criteria:

  • preoperative right ventricular dysfunction
  • cardiac surgery in medical history
  • infective endocarditis
  • primary cardiomyopathies
  • congenital heart disease
  • decreased
  • pulmonary embolism in medical history
  • severe
  • primary pulmonary hypertension
  • any affecting right heart
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
72 participants (actual)
Patient registry
No

Interventions

  • ProcedureMitral valve replacement/repair

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

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What researchers measure

Primary outcomes

  1. right ventricular failure

    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.

    Time frame: From date of operation until the date of first documented right ventricular failure assessed up to 6 months

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Study locations

1 site
  • Semmelweis University Heart and Vascular Center
    Budapest, 1122, Hungary
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References and documents

Publications

  • 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. PubMed 32220010 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03438825
Lead sponsor
Semmelweis University Heart and Vascular Center
Responsible party
Sponsor
First posted
Feb 20, 2018
Start date
Oct 2016
Primary completion
Nov 2018
Completion
Apr 2019
Last update
Apr 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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