Clinical trial NCT02371863: Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic MR
Official title: SEP-study; The Assessment of Normal Values in Stress Echocardiographic Parameters in Patients After Successful Mitral Valve Repair for Organic Mitral Valve Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Mitral Valve Insufficiency
Heart; Dysfunction Postoperative, Cardiac Surgery
Heart; Disease, Mitral(Valve)
Diseases of Mitral Valve
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Echocardiographic parameter: Peak mitral valve mean gradient (mmHg)
timeFrame: at least 6 months after successful MV repair
measure: Echocardiographic parameter: Peak systolic pulmonary artery pressure (sPAP, mmHg)
timeFrame: at least 6 months after successful MV repair
measure: Echocardiographic parameter: Increase in mitral valve regurgitation grade (grade 0-4, according to ESC guidelines)
timeFrame: at least 6 months after successful MV repair
Secondary outcomes:
measure: Echocardiographic parameter: Left ventricular function (LVF, quality description)
timeFrame: at least 6 months after successful MV repair
measure: Echocardiographic parameter: Mitral valve area (MVA, cm2)
timeFrame: at least 6 months after successful MV repair
measure: Echocardiographic parameter: Peak mitral valve peak gradient (mmHg)
timeFrame: at least 6 months after successful MV repair
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht (UMC Utrecht)
Study officials:
affiliation: UMC Utrecht
name: Steven AJ Chamuleau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.