Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR (SEP)

SEP-study; The Assessment of Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic Mitral Valve Regurgitation

Surgical treatment is the only approach with potentially defined clinical success for organic mitral valve (MV) regurgitation. Recurrent or persistent complaints after initial successful MV repair is a clinical challenge in current practice. Especially when echo parameters at rest are within or near normal ranges and patients presenting disproportionately symptomatic in relation to the observed results. However, while MV regurgitation is a hemodynamic disease, currently used 2-dimensional (2D) transthoracic echocardiography (TTE) at rest lacks information about hemodynamic changes. Physical stress echocardiography is a promising technique to complement nowadays rest TTE in order to improve interpretation of hemodynamic changes. However, normal values for exercise echo are lacking in this postoperative patients cohort. A prospective, observational trial to determine normal values in stress echocardiographic parameters in asymptomatic patients after successful MV repair for organic MV regurgitation, is therefore highly needed.

Purpose of the SEP- study is to determine normal values in stress echocardiographic parameters in asymptomatic patients at least 6 months after successful MV repair for organic MV regurgitation. These normal values for stress echo are of utmost importance to correctly and accurate interpret stress echo results during postoperative follow-up and to improve clinical decision making in patients post MV repair.

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases; Mitral Valve Insufficiency; Diseases of Mitral Valve; Heart; Dysfunction Postoperative, Cardiac Surgery; Heart; Disease, Mitral(Valve)

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center Utrecht (UMC Utrecht)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

25 Asymptomatic patients (≥18 years) at least 6 months after successful MV repair. Patients will have a LVEF ≥45%, and were initially operated based on organic MV regurgitation.

Description

Inclusion Criteria:

• Age ≥18 years;
• Male or female from all ethnicities;
• At least 6 months post successful, isolated MV repair. S
• Asymptomatic

Exclusion Criteria:

• Pulmonary hypertension >50 mmHg at rest;
• Atrial fibrillation (AF) at time of study related stress echo test;
• Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing;
• LVEF <45%;
• NYHA class II and more.
• Other heart valve disease of more than mild severity;
• Concomitant surgery during MV repair, e.g. MAZE, TVP procedure;
• Prior heart valve surgery;
• Congenital heart disease;
• Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD);
• Unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)	Echocardiographic measured mitral valve mean gradient at peak physical exercise	at least 6 months after successful MV repair
Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)	Echocardiographic measured sPAP at peak physical exercise	at least 6 months after successful MV repair
Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines)	Echocardiographic measured increase in mitral valve regurgitation at peak physical exercise during physical stress echo, compared to rest echo. Grading of mitral regurgitation will be performed according to the ESC guidelines.	at least 6 months after successful MV repair

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic parameter: Left ventricular function (LVF, quality description)	Echocardiographic measured LVF quality at rest and peak physical exercise	at least 6 months after successful MV repair
Echocardiographic parameter: Mitral valve area (MVA, cm2)	Echocardiographic measured MVA at rest and peak physical exercise	at least 6 months after successful MV repair
Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)	Echocardiographic measured mitral valve peak gradient at peak physical exercise	at least 6 months after successful MV repair

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Steven AJ Chamuleau, MD, PhD, UMC Utrecht

Publications and helpful links

General Publications

• Jansen R, Urgel K, Cramer MJ, van Aarnhem EEHL, Zwetsloot PPM, Doevendans PA, Kluin J, Chamuleau SAJ. Reference Values for Physical Stress Echocardiography in Asymptomatic Patients after Mitral Valve Repair. Front Surg. 2018 Feb 19;5:6. doi: 10.3389/fsurg.2018.00006. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: February 19, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 27, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Mitral Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: NL39865.041.14