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

Mitral Valve Disease Clinical Trial

— PREPARE-MVR  

Official title:

The PREPARE-MVR Study: PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438825
• Other study ID #: PREPARE-MVR1.0
• Status: Completed
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University Heart and Vascular Center	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of operation until the date of first documented right ventricular failure assessed up to 6 months