Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery and it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.
The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR.
However, it remains difficult to determine optimal timing for surgery with the current guidelines.
Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis and longitudinal myocardial function is suitable for detection of minor myocardial damage in patients with MR.
Thus, inestigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF.
The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction.
Condition or disease | Intervention/treatment |
---|---|
Severe Mitral Regurgitation Preserved Ventricular Ejection Fraction | Other: Mitral regurgitation surgery such as mitral valve replacement or repair |
Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery.
In these patients, mitral repair is associated with excellent outcomes in terms of post-operative left ventricular (LV) function, and long-term survival when performed before the onset of severe symptoms, LV dysfunction or dilatation, pulmonary hypertension, and atrial fibrillation.
Thus, it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits.
The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR. LV dysfunction has been defined as LV ejection fraction (EF) 30% to 60% and/or LV end-systolic dimension (ESD) up to 45 mm.
However, it remains difficult to determine optimal timing for surgery with the current guidelines.
LVEF and LVESD, parameters proposed in the guideline, are difficult to interpret due to the influence of hemodynamic parameters of MR.
In asymptomatic patients who consider undergoing surgery, LVESD is rarely more than 45 mm.
In addition, LVEF in patients with severe MR often remains normal or higher, and subclinical LV dysfunction might be masked due to MR lowering of LV afterload.
Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis.
Therefore, it is a great challenge to identify potential LV dysfunction at an early stage and to perform surgery to prevent the development of irreversible LV dysfunction in patients with chronic severe MR.
Longitudinal myocardial function has been considered more sensitive than radial function and is therefore suitable for detection of minor myocardial damage in patients with MR.
A 2017 study proved that pre-operative GLS ≤ -18.4% can predict a preserved post-operative LVEF >50%.
Therefore, invetsigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF.
The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction.
Thus, investigators will recruit patients before surgery, measuring GLS during pre-operative conventional echography, and follow-up patients at 8 days, 1 month and 6 months to determine whether LVEF is preserved or not.
Study Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prediction of Post-operative Left Ventricular Dysfunction in Primitive, Chronic Mitral Regurgitation Surgery With Preserved Ejection Fraction, by Pre-operative Global Longitudinal Strain Measure |
Actual Study Start Date : | March 18, 2019 |
Estimated Primary Completion Date : | October 31, 2022 |
Estimated Study Completion Date : | October 31, 2022 |
Group/Cohort | Intervention/treatment |
---|---|
cohorte 1
Severe primary chronic mitral regurgitation with preserved left ventricular ejection fraction.
|
Other: Mitral regurgitation surgery such as mitral valve replacement or repair
Mitral regurgitation surgery such as mitral valve replacement or repair. All kind of mitral regurgitation surgery: replacement or repair, by median sternotomy of minimally invasive surgery, with or without tricuspid plasty
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with another form of cardiopathy, such as dilated or hypertrophic cardiomyopathy, ischemic or rhythmic cardiopathy.
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Lise Laclautre | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
France | |
CHU de Clermont-Ferrand | Recruiting |
Clermont-Ferrand, France, 63000 | |
Contact: Lise Laclautre promo_interne_drci@chu-clermontferrand.fr | |
Principal Investigator: Guillaume Clerfond |
Principal Investigator: | Guillaume Clerfond | University Hospital, Clermont-Ferrand |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | April 5, 2019 | ||||
First Posted Date | May 30, 2019 | ||||
Last Update Posted Date | April 30, 2021 | ||||
Actual Study Start Date | March 18, 2019 | ||||
Estimated Primary Completion Date | October 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Pre-operative global longitudinal strain rate among patients going for mitral surgery. [ Time Frame: During pre-operative visit ] Pre-operative global longitudinal strain in patients going for mitral regurgitation surgery with preserved LVEF, measured by echocardiography.
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery | ||||
Official Title | Prediction of Post-operative Left Ventricular Dysfunction in Primitive, Chronic Mitral Regurgitation Surgery With Preserved Ejection Fraction, by Pre-operative Global Longitudinal Strain Measure | ||||
Brief Summary |
Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery and it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits. The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR. However, it remains difficult to determine optimal timing for surgery with the current guidelines. Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis and longitudinal myocardial function is suitable for detection of minor myocardial damage in patients with MR. Thus, inestigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF. The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction. |
||||
Detailed Description |
Primary mitral regurgitation (MR) is the second most frequent valve disease requiring surgery. In these patients, mitral repair is associated with excellent outcomes in terms of post-operative left ventricular (LV) function, and long-term survival when performed before the onset of severe symptoms, LV dysfunction or dilatation, pulmonary hypertension, and atrial fibrillation. Thus, it is important to identify patients whose outcome could be improved with surgery by considering the risks and benefits. The current guidelines recommend surgery in patients with symptomatic severe mitral regurgitation or in asymptomatic patients who develop early signs of left ventricular (LV) dysfunction as a result of the MR. LV dysfunction has been defined as LV ejection fraction (EF) 30% to 60% and/or LV end-systolic dimension (ESD) up to 45 mm. However, it remains difficult to determine optimal timing for surgery with the current guidelines. LVEF and LVESD, parameters proposed in the guideline, are difficult to interpret due to the influence of hemodynamic parameters of MR. In asymptomatic patients who consider undergoing surgery, LVESD is rarely more than 45 mm. In addition, LVEF in patients with severe MR often remains normal or higher, and subclinical LV dysfunction might be masked due to MR lowering of LV afterload. Early-stage LV dysfunction with normal LVEF predicts post-operative LV decompensation and poor prognosis. Therefore, it is a great challenge to identify potential LV dysfunction at an early stage and to perform surgery to prevent the development of irreversible LV dysfunction in patients with chronic severe MR. Longitudinal myocardial function has been considered more sensitive than radial function and is therefore suitable for detection of minor myocardial damage in patients with MR. A 2017 study proved that pre-operative GLS ≤ -18.4% can predict a preserved post-operative LVEF >50%. Therefore, invetsigators want to study the value of LV global longitudinal strain (GLS) to predict postoperative LV dysfunction in patients with chronic severe MR and preserved pre-operative LVEF. The principal aim is to prove that the optimal timing for surgery, in asymptomatic chronic severe primary MR with preserved LVEF, is before GLS alteration, and that investigators should not wait for LV dilatation of dysfunction. Thus, investigators will recruit patients before surgery, measuring GLS during pre-operative conventional echography, and follow-up patients at 8 days, 1 month and 6 months to determine whether LVEF is preserved or not. |
||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population |
Patients with another form of cardiopathy, such as dilated or hypertrophic cardiomyopathy, ischemic or rhythmic cardiopathy.
|
||||
Condition |
|
||||
Intervention | Other: Mitral regurgitation surgery such as mitral valve replacement or repair
Mitral regurgitation surgery such as mitral valve replacement or repair. All kind of mitral regurgitation surgery: replacement or repair, by median sternotomy of minimally invasive surgery, with or without tricuspid plasty
|
||||
Study Groups/Cohorts | cohorte 1
Severe primary chronic mitral regurgitation with preserved left ventricular ejection fraction.
Intervention: Other: Mitral regurgitation surgery such as mitral valve replacement or repair
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
60 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | October 31, 2022 | ||||
Estimated Primary Completion Date | October 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: - |
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
|
||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03968601 | ||||
Other Study ID Numbers | RNI 2018 CLERFOND 2018-A02476-49 ( Other Identifier: 2018-A02476-49 ) |
||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | University Hospital, Clermont-Ferrand | ||||
Study Sponsor | University Hospital, Clermont-Ferrand | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | University Hospital, Clermont-Ferrand | ||||
Verification Date | April 2021 |