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出境医 / 临床实验 / Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation (IM EFFORT)

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

Study Description
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 ...).


Condition or disease
Cardiac Disease

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation
Actual Study Start Date : July 3, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Aggravation of secondary mitral insuffiency [ Time Frame: Day 1 ]
    Il will measure an increase of the grade of severity of at least 1/4 compared to the rest.

  2. Aggravation of secondary mitral insuffiency [ Time Frame: Day 1 ]
    Il will measure an increase of the ORS of more than 0.5 cm² in case of IM Grade 4 at rest.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Contacts and Locations

Locations
Layout table for location information
France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
Layout table for investigator information
Principal Investigator: Philippe Garçon, MD Groupe Hospitalier Paris Saint Joseph
Tracking Information
First Submitted Date June 3, 2019
First Posted Date June 7, 2019
Last Update Posted Date February 5, 2020
Actual Study Start Date July 3, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019)
  • Aggravation of secondary mitral insuffiency [ Time Frame: Day 1 ]
    Il will measure an increase of the grade of severity of at least 1/4 compared to the rest.
  • Aggravation of secondary mitral insuffiency [ Time Frame: Day 1 ]
    Il will measure an increase of the ORS of more than 0.5 cm² in case of IM Grade 4 at rest.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation
Official Title Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation
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 ...).

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Cardiac Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2019)
87
Original Estimated Enrollment Same as current
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03978676
Other Study ID Numbers IM EFFORT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Principal Investigator: Philippe Garçon, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date February 2020