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
- Heart Valve Diseases
- Mitral Valve Insufficiency
- Heart; Dysfunction Postoperative, Cardiac Surgery
- Heart; Disease, Mitral(Valve)
- Diseases of Mitral Valve
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.