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

NCT03968601 | Completed

• 2 other identifiers: RNI 2018 CLERFOND2018-A02476-49
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mitral Regurgitation; Preserved Ventricular Ejection Fraction

Keywords

Severe mitral regurgitation; Preserved ventricular ejection fraction; Global Longitudinal Strain; Post-operative ventricular dysfunction; Echocardiography; Mitral surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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.

• 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

Study Arms (1)

cohorte 1

Severe primary chronic mitral regurgitation with preserved left ventricular ejection fraction.

Other: Mitral regurgitation surgery such as mitral valve replacement or repair

Interventions

Mitral regurgitation surgery such as mitral valve replacement or repair OTHER

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

cohorte 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Guillaume Clerfond

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: May 30, 2019
• Study Start: March 18, 2019
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Locations

FR (1)