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

Completed

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

• Registration Number: NCT02371863
• Lead Sponsor: UMC Utrecht

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-07
• Study Start: 2014-12
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-26
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-27
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)	at least 6 months after successful MV repair	Echocardiographic measured mitral valve mean gradient at peak physical exercise
Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)	at least 6 months after successful MV repair	Echocardiographic measured sPAP at peak physical exercise
Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines)	at least 6 months after successful MV repair	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Utrecht (UMC Utrecht); 🇳🇱 Utrecht, Netherlands