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

• Sponsor: Semmelweis University Heart and Vascular Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03438825
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Actual Duration (Months): 30
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	Phase
Right Heart Failure; Right Ventricular Dysfunction; Right Ventricular Failure; Mitral Valve Disease	Procedure: Mitral valve replacement/repair

Study Design

• Study Type: Observational
• Actual Enrollment: 72 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: Oct 1, 2016
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Apr 1, 2019

Outcome Measures

Primary Outcome Measures

1. right ventricular failure [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University Heart and Vascular Center	Budapest		Hungary	1122

Sponsors and Collaborators

• Semmelweis University Heart and Vascular Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Semmelweis University Heart and Vascular Center
• ClinicalTrials.gov Identifier: NCT03438825
• Other Study ID Numbers: PREPARE-MVR1.0
• First Posted: Feb 20, 2018
• Last Update Posted: Apr 4, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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

Study Results

No Results Posted as of Apr 4, 2019