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

NCT03438825 | Completed

• 1 other identifier: PREPARE-MVR1.0
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

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

Interventions

Mitral valve replacement/repair PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with isolated severe mitral valve insufficiency admitted for replacement/repair surgery as described in inclusion, exclusion criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead

Study Sites (1)

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (1)

• 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.

  PMID: 32220010 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction, Right

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 20, 2018
• Study Start: October 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

HU (1)