University Medical Center Utrecht (UMC Utrecht)
Utrecht, 3584 CX, Netherlands
NCT Number: NCT02371863
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.
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Notify Me18 year and older
All sexes
Observational
Utrecht, 3584 CX, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at least 6 months after successful MV repair
Echocardiographic measured mitral valve mean gradient at peak physical exercise
Time frame: at least 6 months after successful MV repair
Echocardiographic measured sPAP at peak physical exercise
Time frame: 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.
Time frame: at least 6 months after successful MV repair
Echocardiographic measured LVF quality at rest and peak physical exercise
Time frame: at least 6 months after successful MV repair
Echocardiographic measured MVA at rest and peak physical exercise
Time frame: at least 6 months after successful MV repair
Echocardiographic measured mitral valve peak gradient at peak physical exercise
UMC Utrecht
Other
SEP-study; The Assessment of Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic Mitral Valve Regurgitation
Acronym: SEP
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