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 non-invasive 2D stress echo testing are of utmost…
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Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine normal values in stress echocardiographic parameters in
asymptomatic patients at least 6 months after successful MV repair, including
but not limited to the following 2D stress echo parameters: mean gradient (MG)
and peak gradient over the repaired MV, systolic pulmonary artery values
(sPAP), left ventricular end diastolic dimensions (LVEDD), left ventricular end
systolic dimensions (LVEDS), left atrium (LA) dimensions, ejection fraction
(EF), mitral valve area (MVA) and severity of MV regurgitation (grade 1-4).
Secondary outcome
Secondary objective is to compare 2D echocardiographic parameters during
physical exercise to 3D stress echo parameters (including but not limited to
the following 2D and 3D stress echo parameters: mean gradient (MG) and peak
gradient over the repaired MV, systolic pulmonary artery values (sPAP), left
ventricular end diastolic dimensions (LVEDD), left ventricular end systolic
dimensions (LVEDS), left atrium (LA) dimensions, ejection fraction (EF), mitral
valve area (MVA) and severity of MV regurgitation (grade 1-4)).
Background 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 2D stress echocardiography is a promising technique to complement
nowadays rest TTE in order to improve interpretation of hemodynamic changes. In
addition, 3-dimensional (3D) echo is useful to describe the morphoanatomy and
physiology of the MV during stress and to define an approach for accurate
quantification. However,2D normal values for exercise echo are lacking in this
postoperative patients cohort. A observational trial to determine 2D normal
values in stress echocardiographic parameters in asymptomatic patients after
successful MV repair for organic MV regurgitation, is therefore highly needed.
Study objective
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 non-invasive 2D stress echo testing
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. In addition 2D stress echo parameters will be
compared to 3D echocardiographic measurements during physical exercise.
Study design
Single centre, cross-sectional study.
We will perform physical stress echoes (2D and 3D) in 25 study patients.
Patients will be recruited from the heart valve surgery database of the UMC
Utrecht.
Study burden and risks
An extra follow-up visit at least 6 months after successful MV repair is
planned in view of the trial at the UMC Utrecht study center. During this visit
(approximately taking 1 hour) an exercise echocardiogram will be performed on a
semi-supine bicycle. Rare but serious complications in exercise testing are
reported in one out of ten thousand patients, which can be easily stratified in
advance based on resting electrocardiogram (ECG), medical history and risk
factors. Exercise testing is immediately stopped when complaints occur. Safety
is furthermore guaranteed by the attendance of a medical doctor during the
exercise test.
Heidelberglaan 100 E 03 511
Utrecht 3584 CX
NL
Heidelberglaan 100 E 03 511
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Age >=18 years;
- Male or female from all ethnicities;
- At least 6 months post successful, isolated MV repair. Successful MV repair: when
there is no or grade 1+ residual or recurrent MV regurgitation, MG <10 mmHg and
MVA >1.5 cm2 after MV surgery and during follow-up. Isolated MV surgery may
include a coronary artery bypass graft (CABG);
- No symptoms (asymptomatic). Symptoms are defined as subjective limitations of
exercise capacity or complaints expressed by the patient and confirmed by the
treating cardiologist;
Exclusion criteria
- Pulmonary hypertension >50 mmHg at rest;
- Atrial fibrillation (AF) at time of study related stress echo testing;
- 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;
- Heart valve surgery prior to MV repair;
- Congenital heart disease;
- Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD);
- Unable to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39865.041.14 |