DysPO IM
Prediction of Post-operative Left Ventricular Dysfunction in Primitive, Chronic Mitral Regurgitation Surgery With Preserved Ejection Fraction, by Pre-operative Global Longitudinal Strain Measure
Sponsor study identifier
Secondary identifiers
OTHER · 2018-A02476-49
observational
79
1 country
1
Study Start
March 18, 2019
Actual (reported)Primary Completion
April 29, 2022
Actual (reported)Study Completion
April 29, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 29, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2019
Actual (reported)April 5, 2019
Actual (reported)May 30, 2019
Actual (reported)April 29, 2022
Actual (reported)April 29, 2022
Actual (reported)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.
During pre-operative visit
Functional impact in terms of walking distance.
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)
This test will be realized during pre-operative visit and repeated at 1-month and 6-months visits.
Severe primary chronic mitral regurgitation with preserved left ventricular ejection fraction.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
Guillaume Clerfond
University Hospital, Clermont-Ferrand
79 participants (actual enrollment reported by the registry).
First Submitted
April 5, 2019
First Posted
May 30, 2019
Study Start
March 18, 2019
Actual (reported)Dyspnoea
This test will be realized during pre-operative visit and repeated at 8-days, 1-month and 6-months visits.
Left ventricular function
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
At 8 days, 1-month and 6-months
Contact the study team to confirm eligibility.
Primary Completion
April 29, 2022
Actual (reported)Study Completion
April 29, 2022
Actual (reported)Last Updated
November 9, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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