Severe Mitral RegurgitationDysPO IMNCT03968601
Use of Pre-operative Global Longitudinal Strain to Predict Post-operative Left Ventricular Dysfunction in Mitral Regurgitation Surgery
An observational study of Severe Mitral Regurgitation and Preserved Ventricular Ejection Fraction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mitral Regurgitation, Preserved Ventricular Ejection Fraction
- What is being tested?
- Mitral regurgitation surgery such as mitral valve replacement or repair
- How many people
- 79 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2019to 29 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Mitral regurgitation surgery such as mitral valve replacement or repair
- Keywords
- Severe mitral regurgitation, Preserved ventricular ejection fraction, Global Longitudinal Strain, Post-operative ventricular dysfunction, Echocardiography, Mitral surgery
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral regurgitation surgery such as mitral valve replacement or repairOther
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 group | Role | What they receive |
|---|---|---|
| cohorte 1 | Severe primary chronic mitral regurgitation with preserved left ventricular ejection fraction. Receives: Other: Mitral regurgitation surgery such as mitral valve replacement or repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative global longitudinal strain rate among patients going for mitral surgery.
Pre-operative global longitudinal strain in patients going for mitral regurgitation surgery with preserved LVEF, measured by echocardiography.
Measured: During pre-operative visit
Secondary outcomes (10)
Functional impact in terms of walking distance.
6 Minute Walk Distance
Measured: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Measure Quality of life: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
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).
Measured: This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Dyspnoea
Use of the New York Heart Association (NYHA) Functional Classification.
Measured: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
Left ventricular function
Left ventricular ejection fraction by Simpson method.
Measured: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
All-cause mortality, as the total number of death during the follow-up
all death reported
Measured: At 8 days, 1-month and 6-months
Cardiovascular mortality, as the number of death from cardiovascular disease during the follow up
Death by myocardial ischemia or infarction, heart failure, cardiac arrest, or cerebrovascular accident.
Measured: At 8 days, 1-month and 6-months
Number of patients hospitalized due to heart failure during the follow up
all re-hospitalisation reported
Measured: At 8 days, 1-month and 6-months
Pre-operative right ventricular function (measured by Tricuspid Annular Plane Systolic Excursion - TAPSE, Peak Systolic Velocity in DTI mode and Fractional Area Change).
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.
Measured: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits
Pre-operative pulmonary arterial pressure determined by tricuspid regurgitation peak velocity
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.
Measured: These measures will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Left ventricular ejection index
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.
Measured: During pre-operative visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start18 Mar 2019
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Clerfond, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968601
- Sponsor's protocol ID
- RNI 2018 CLERFOND
- Other IDs
- 2018-A02476-49
- Acronym
- DysPO IM
- Status last verified
- Nov 2022
- First submitted
- 5 Apr 2019
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03968601
- Acronym / sponsor ID
- DysPO IM / RNI 2018 CLERFOND
- Keywords
- Severe mitral regurgitation, Preserved ventricular ejection fraction, Global Longitudinal Strain, Post-operative ventricular dysfunction, Echocardiography, Mitral surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohorte 1 | – | Other: Mitral regurgitation surgery such as mitral valve replacement or repairSevere primary chronic mitral regurgitation with preserved left ventricular ejection fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral regurgitation surgery such as mitral valve replacement or repairMitral 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 | Other | cohorte 1 |
Primary outcome
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.
10 secondary outcomes
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.
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.
Dyspnoea
Time frame: This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
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.
All-cause mortality, as the total number of death during the follow-up
Time frame: At 8 days, 1-month and 6-months
Cardiovascular mortality, as the number of death from cardiovascular disease during the follow up
Time frame: At 8 days, 1-month and 6-months
Number of patients hospitalized due to heart failure during the follow up
Time frame: At 8 days, 1-month and 6-months
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
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.
Left ventricular ejection index
Time frame: During pre-operative visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Clerfond principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mitral Regurgitation and Preserved Ventricular Ejection Fraction, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative global longitudinal strain rate among patients going for mitral surgery. (time frame: During pre-operative visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.