Right Heart FailurePREPARE-MVRNCT03438825
PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
An observational study of Right Heart Failure and Right Ventricular Dysfunction, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure
- What is being tested?
- Mitral valve replacement/repair
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteHungary
- Study dates
- Oct 2016to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with isolated severe mitral valve insufficiency admitted for replacement/repair surgery as described in inclusion, exclusion criteria
Who may be able to join
- patients admitted for mitral valve replacement/repair
- severe mitral valve insufficiency
Who cannot join
- preoperative right ventricular dysfunction
- cardiac surgery in medical history
- infective endocarditis
- primary cardiomyopathies
- congenital heart disease
- decreased left ventricular ejection fraction
Show all 10Show fewer
- pulmonary embolism in medical history
- severe chronic obstructive pulmonary disease
- primary pulmonary hypertension
- any malignancy affecting right heart
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Right Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure, Mitral Valve Disease
- Being tested
- Mitral valve replacement/repair
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve replacement/repairProcedure or surgery
Mitral valve replacement/repair: standard of care operation of the mitral valve due to severe insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of operation until the date of first documented right ventricular failure assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startOct 2016
- Primary completionNov 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Right Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438825
- Sponsor's protocol ID
- PREPARE-MVR1.0
- Acronym
- PREPARE-MVR
- Status last verified
- Apr 2019
- First submitted
- 11 Feb 2018
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREPARE-MVR Study: PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
- ClinicalTrials.gov ID
- NCT03438825
- Acronym / sponsor ID
- PREPARE-MVR / PREPARE-MVR1.0
- Conditions
- Right Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure, Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with isolated severe mitral valve insufficiency admitted for replacement/repair surgery as described in inclusion, exclusion criteria
Key inclusion criteria (2 listed)
- patients admitted for mitral valve replacement/repair
- severe mitral valve insufficiency
Key exclusion criteria (10 listed)
- preoperative right ventricular dysfunction
- cardiac surgery in medical history
- infective endocarditis
- primary cardiomyopathies
- congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral valve replacement/repairMitral valve replacement/repair: standard of care operation of the mitral valve due to severe insufficiency | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Derived from this study: PubMed 32220010Tokodi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Heart Failure and Right Ventricular Dysfunction, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
right ventricular failure (time frame: From date of operation until the date of first documented right ventricular failure assessed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03438825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.