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出境医 / 临床实验 / Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery (DysPO IM)

Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery (DysPO IM)

Study Description
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.


Condition or disease Intervention/treatment
Severe Mitral Regurgitation Preserved Ventricular Ejection Fraction Other: Mitral regurgitation surgery such as mitral valve replacement or repair

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 Design
Layout table for study information
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
Arms and Interventions
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

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Functional impact in terms of walking distance. [ Time Frame: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits. ]
    6 Minute Walk Distance

  2. Measure Quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits. ]
    Minnesota Living with Heart Failure Questionnaire (MLHFQ), evaluating : legs swelling, walking and working capacity, presence of sleeping or breathing disorders, difficulties for sport, hobbies or relationships, side effects from medications, psychologic and economic impact of the disease. The total score goes from 0 (best quality of life) to 105 (worse impact).

  3. Dyspnoea [ Time Frame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits. ]
    Use of the New York Heart Association (NYHA) Functional Classification.

  4. Left ventricular function [ Time Frame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits. ]
    Left ventricular ejection fraction by Simpson method.

  5. All-cause mortality, as the total number of death during the follow-up [ Time Frame: At 8 days, 1-month and 6-months ]
    all death reported

  6. Cardiovascular mortality, as the number of death from cardiovascular disease during the follow up [ Time Frame: At 8 days, 1-month and 6-months ]
    Death by myocardial ischemia or infarction, heart failure, cardiac arrest, or cerebrovascular accident.

  7. Number of patients hospitalized due to heart failure during the follow up [ Time Frame: At 8 days, 1-month and 6-months ]
    all re-hospitalisation reported

  8. Pre-operative right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change). [ Time Frame: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits ]
    We aim to determine whether or not right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change) can have an impact on post-operative LVEF in patients going for mitral regurgitation surgery.

  9. Pre-operative pulmonary arterial pressure determined by tricuspid regurgitation peak velocity [ Time Frame: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits. ]
    Ithe aim is to determine whether or not pulmonary hypertension (determined by tricuspid regurgitation peak velocity) can have an impact on post-operative LVEF in patients going for mitral regurgitation surgery.

  10. Left ventricular ejection index [ Time Frame: During pre-operative visit. ]
    Impact of this novel left ventricular ejection index (defined as indexed left ventricular end-systolic diameter divided by left ventricular outflow tract time-velocity integral) on post-operative left ventricular dysfunction, compared with global longitudinal strain.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with another form of cardiopathy, such as dilated or hypertrophic cardiomyopathy, ischemic or rhythmic cardiopathy.

  • Patients with another valvular heart disease, such as significant aortic regurgitation or stenosis and significant mitral stenosis.
  • Poor echogenicity, insufficient for the different measures.
  • Severe pulmonary disease, inducing pulmonary hypertension.
  • Other causes of pulmonary hypertension.
  • Patients included in other studies with interventions able to interfere with our measures.
  • Pregnant women.
Criteria

Inclusion Criteria:

  • Stage 3 or 4, primary and chronic mitral regurgitation, going for a planned surgery, with pre-operative left ventricular ejection fraction > 60% and left ventricular end-systolic dimension < 45mm.
  • Able to consent.
  • With a National Social Security number.

Exclusion Criteria:

-

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
Layout table for location information
France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63000
Contact: Lise Laclautre       promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Guillaume Clerfond         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Layout table for investigator information
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
 (submitted: May 27, 2019)
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
 (submitted: May 27, 2019)
  • Functional impact in terms of walking distance. [ Time Frame: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits. ]
    6 Minute Walk Distance
  • Measure Quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ) [ Time Frame: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits. ]
    Minnesota Living with Heart Failure Questionnaire (MLHFQ), evaluating : legs swelling, walking and working capacity, presence of sleeping or breathing disorders, difficulties for sport, hobbies or relationships, side effects from medications, psychologic and economic impact of the disease. The total score goes from 0 (best quality of life) to 105 (worse impact).
  • Dyspnoea [ Time Frame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits. ]
    Use of the New York Heart Association (NYHA) Functional Classification.
  • Left ventricular function [ Time Frame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits. ]
    Left ventricular ejection fraction by Simpson method.
  • All-cause mortality, as the total number of death during the follow-up [ Time Frame: At 8 days, 1-month and 6-months ]
    all death reported
  • Cardiovascular mortality, as the number of death from cardiovascular disease during the follow up [ Time Frame: At 8 days, 1-month and 6-months ]
    Death by myocardial ischemia or infarction, heart failure, cardiac arrest, or cerebrovascular accident.
  • Number of patients hospitalized due to heart failure during the follow up [ Time Frame: At 8 days, 1-month and 6-months ]
    all re-hospitalisation reported
  • Pre-operative right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change). [ Time Frame: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits ]
    We aim to determine whether or not right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change) can have an impact on post-operative LVEF in patients going for mitral regurgitation surgery.
  • Pre-operative pulmonary arterial pressure determined by tricuspid regurgitation peak velocity [ Time Frame: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits. ]
    Ithe aim is to determine whether or not pulmonary hypertension (determined by tricuspid regurgitation peak velocity) can have an impact on post-operative LVEF in patients going for mitral regurgitation surgery.
  • Left ventricular ejection index [ Time Frame: During pre-operative visit. ]
    Impact of this novel left ventricular ejection index (defined as indexed left ventricular end-systolic diameter divided by left ventricular outflow tract time-velocity integral) on post-operative left ventricular dysfunction, compared with global longitudinal strain.
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.

  • Patients with another valvular heart disease, such as significant aortic regurgitation or stenosis and significant mitral stenosis.
  • Poor echogenicity, insufficient for the different measures.
  • Severe pulmonary disease, inducing pulmonary hypertension.
  • Other causes of pulmonary hypertension.
  • Patients included in other studies with interventions able to interfere with our measures.
  • Pregnant women.
Condition
  • Severe Mitral Regurgitation
  • Preserved Ventricular Ejection Fraction
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
 (submitted: May 27, 2019)
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:

  • Stage 3 or 4, primary and chronic mitral regurgitation, going for a planned surgery, with pre-operative left ventricular ejection fraction > 60% and left ventricular end-systolic dimension < 45mm.
  • Able to consent.
  • With a National Social Security number.

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor University Hospital, Clermont-Ferrand
Collaborators Not Provided
Investigators
Principal Investigator: Guillaume Clerfond University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date April 2021