Cardiac DiseaseIM EFFORTNCT03978676
Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation
An observational study of Cardiac Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Patient with cardiac valve prosthesis
- Hypertrophic or restrictive cardiomyopathy
- Patient with congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggravation of secondary mitral insuffiency
Il will measure an increase of the grade of severity of at least 1/4 compared to the rest.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start3 Jul 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Garçon, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978676
- Sponsor's protocol ID
- IM EFFORT
- Acronym
- IM EFFORT
- Status last verified
- Feb 2020
- First submitted
- 3 Jun 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-induced in Secondary Mitral Regurgitation: Analysis of Echocardiographic Parameters at Rest Predicting the Onset of Significant Exercise-induced Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT03978676
- Acronym / sponsor ID
- IM EFFORT / IM EFFORT
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 ...).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Garçon, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggravation of secondary mitral insuffiency (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.