Clinical Trials Directory

Trials / Completed

CompletedNCT02371863

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
25 (actual)
Sponsor
UMC Utrecht · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2014-12-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2015-02-26
Last updated
2015-12-29

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02371863. Inclusion in this directory is not an endorsement.