MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease
ConditionValvular Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFrench Cardiology Society
About this trial
Multiple and mixed valvular heart disease (MMVD) is a common condition in clinical practice. It corresponds to a combination of stenotic or leaky lesions on two or more heart valves (multiple valve disease), or a combination of stenotic and leaky lesions on the same valve (mixed valve disease). However, the management of their clinical, biological and cardiovascular imaging is not well established. Current European Society of Cardiology (ESC) recommendations primarily address the various valve diseases in isolation. This results in an absence of reliable recommendations for managing MMVD, with different approaches being adopted by care centres.
In order to address this knowledge gap regarding MMVD, it is crucial to assess its prevalence, the cardiovascular imaging methods employed and the management strategies, as well as to identify prognostic factors for the various combinations of valve disease.
The multicentre MMVD study will be a valuable resource as it will improve our understanding of the prognosis for patients with MMVD. It will highlight imaging and biological markers associated with the prognosis of different combinations of MMVD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
The patient has been informed of the study and has not refused to participate.
An echocardiographic diagnosis of MMVD is defined as having at least two moderate to severe valvulopathies, as assessed by a cardiologist using transthoracic echocardiography (TTE), on one or more valves. This is in line with the recommendations of the ESC, the ASE, and expert opinion.
Disqualifiers
History of valve surgery or percutaneous valve intervention involving the valve in question.
A history of infective endocarditis, whether treated surgically or not, confirmed according to the modified Duke criteria.
Acute infective endocarditis at the time of evaluation for inclusion, confirmed according to the modified Duke criteria.
Complex congenital heart disease.
Trial population
Patients with a diagnosis of MMVD based on cardiovascular imaging and defined as follows: At least two cases of moderate to severe valvular heart disease, as assessed by a cardiologist and defined by transthoracic echocardiography (TTE) on one or more valves. This is in line with the recommendations of the European Society of Cardiology (ESC), the American Society of Echocardiography (ASE) and expert opinion.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Patients with a diagnosis of MMVD
Trial outcomes
Primary outcomes
1
To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD.
Survival without cardiovascular event
Time frame
1 year after inclusionSecondary outcomes
1
To assess the association between cardiovascular imaging parameters and survival
Time frame
at 1, 2, 3, 4 and 5 years after inclusion2
Proportion of patients who did not experience a cardiovascular event
Time frame
at 1, 2, 3, 4 and 5 years after inclusion3
Proportion of patients who are alive
Time frame
at 1, 2, 3, 4 and 5 years after inclusion4
Proportion of patients who did not experience a cardiovascular event depending on the type of treatment (medical, surgical or percutaneous)
Time frame
at 1, 2, 3, 4 and 5 years after inclusionSponsors and contacts
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Source ClinicalTrials.gov