Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation

NCT03978676 | Completed

• 1 other identifier: IM EFFORT
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Secondary mitral insufficiency is a common complication of heart failure, aggravating symptoms and prognosis, and may be responsible for worsening dyspnea, pulmonary edema, and excess mortality. It is essentially a ventricular rather than a valvular disease, whose origin may be ischemic or not. It is induced by a geometrical and contractile modification of the left ventricle which causes an imbalance between the tensile and the closing forces of the mitral valve thus causing a defect of coaptation and the increase of the surface between the mitral leaves and the ring in systole (tenting). Dynamic mitral insufficiency is defined by changes in the degree of severity of regurgitation as a function of hemodynamic conditions. During exercise, the course of mitral insufficiency is variable and is not predicted by the degree of regurgitation at rest. The worsening of the leak is also well correlated with the onset of dyspnea on exertion in patients with left Ventricular Ejection Fraction heart failure (LVEF reduced). Nevertheless, there is little data available in the literature on the factors predisposing to the development of stress-related mitral insufficiency, as well as its clinical and echocardiographic impact in the cardiac insufficiency patient, particularly in the case of preserved LVEF (6.7%). The identification of echocardiographic data at rest to predict and anticipate the behavior of mitral insufficiency in the effort (aggravation or stability / disappearance), would allow a simplified evaluation and a better management in this population of patients for which the evaluation in echography of effort can be technically complex and limited (difficulty of quantification of the mitral leak, time of effort sometimes too short ...).

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (2)

• Aggravation of secondary mitral insuffiency

  Il will measure an increase of the grade of severity of at least 1/4 compared to the rest.

  Day 1

• Aggravation of secondary mitral insuffiency

  Il will measure an increase of the ORS of more than 0.5 cm² in case of IM Grade 4 at rest.

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who received a stress echocardiography performed by an experienced operator in the evaluation of mitral insufficiency at the Paris Saint-Joseph Hospital Group between March 2016 and February 2019 and presenting during this ultrasound a mitral insufficiency secondary to rest and effort

You may qualify if:

• Patient whose age is ≥ 18 years
• Patient who received a stress echocardiography performed by an experienced operator in the evaluation of mitral insufficiency at the Paris Saint-Joseph Hospital Group between March 2016 and February 2019
• Patient presenting during this ultrasound a mitral insufficiency secondary to rest and effort
• Francophone patient

You may not qualify if:

• Patients under guardianship or curatorship
• Patients deprived of their liberty
• Patients who oppose the use of their data for this research
• Patient with primary mitral insufficiency, structural abnormality of valvular leaflets
• Patient with valvular or valvular calcification
• Patient with other significant associated valvulopathy (grade\> II / IV: corresponds to the severity of mitral leak quantified on cardiac ultrasound)
• Patient with cardiac valve prosthesis
• Hypertrophic or restrictive cardiomyopathy
• Patient with congenital heart disease

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Philippe Garçon, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 7, 2019
• Study Start: July 3, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

FR (1)