MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Valvular Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
National, Prospective, Multicentric Registry. Patients with a diagnosis of MMVD identified by echocardiography will be included and followed up at 1, 2, 3, 4 and 5 years.
Primary outcome measures
- To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD. [Time frame: 1 year after inclusion]
Secondary outcome measures (11)
- To assess the association between cardiovascular imaging parameters and survival [Time frame: at 1, 2, 3, 4 and 5 years after inclusion]
- Proportion of patients who did not experience a cardiovascular event [Time frame: at 1, 2, 3, 4 and 5 years after inclusion]
- Proportion of patients who are alive [Time frame: at 1, 2, 3, 4 and 5 years after inclusion]
- 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 inclusion]
- Proportion of patients who are alive depending on the type of treatment (medical, surgical or percutaneous) [Time frame: at 1, 2, 3, 4 and 5 years after inclusion]
- To assess the progression of the stage of severity of valvulopathy [Time frame: at 1, 2, 3, 4 and 5 years after inclusion]
- % of patients with MMVD combinations [Time frame: during 5 years after inclusion]
- Measurement of cardiovascular biomarkers [Time frame: at baseline and 1, 2, 3, 4 and 5 years after inclusion]
- Assessing the association between cardiovascular biomarkers in patients with MMVD and survival [Time frame: during 5 years after inclusion]
- Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survival [Time frame: during 5 years after inclusion]
- Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional) [Time frame: at baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Patients who are already included in the European EACVI-MMVD study.
- Pregnant women
- Patients not affiliated to social security
- Patients who are minors
- Patients under guardianship, curatorship or judicial supervision
- Patients who refuse to participate in this register.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- Chu Lille- Hopital Cardiologique — Lille
- Chu Lariboisiere (Aphp) — Paris
Identifiers
NCT: NCT07176507 · 2023-A02626-39