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NCT Number: NCT07176507
MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Chu Lille- Hopital Cardiologique, Lille, France
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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
Survival without cardiovascular event
Secondary outcomes
-
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
Echocardiography
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% 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
BNP or NT-pro-BNP and troponin
-
Assessing the association between cardiovascular biomarkers in patients with MMVD and survival
Time frame: during 5 years after inclusion
BNP or NT-pro-BNP and troponin, vital status
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Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survival
Time frame: during 5 years after inclusion
BNP or NT-pro-BNP and troponin, Survival without cardiovascular event
-
Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional)
Time frame: at baseline
Biobank (optional)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
French Cardiology Society
Other
Registry information
Acronym: MULTIVALVE
Important dates
- Study start
- 2025
- Primary completion
- 2028
- Study completion
- 2032
- First posted
- Sep 16, 2025
- Registry last updated
- Jun 12, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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