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

Cardiac Disease Clinical Trial

— IM EFFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03978676
• Other study ID #: IM EFFORT
• Status: Completed
• Start date: July 3, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ...).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Mitral Valve Insufficiency

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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