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MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease

MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07176507
Acronym
MULTIVALVE
Enrollment
1000
Registered
2025-09-16
Start date
2025-10-30
Completion date
2032-10-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular Heart Disease

Keywords

valvular heart disease, Multiple and mixed valvular heart disease, multiple valve disease

Brief summary

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.

Interventions

None listed

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD.1 year after inclusionSurvival without cardiovascular event

Secondary

MeasureTime frameDescription
To assess the association between cardiovascular imaging parameters and survivalat 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who did not experience a cardiovascular eventat 1, 2, 3, 4 and 5 years after inclusion
Proportion of patients who are aliveat 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)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)at 1, 2, 3, 4 and 5 years after inclusion
To assess the progression of the stage of severity of valvulopathyat 1, 2, 3, 4 and 5 years after inclusionEchocardiography
% of patients with MMVD combinationsduring 5 years after inclusion
Measurement of cardiovascular biomarkersat baseline and 1, 2, 3, 4 and 5 years after inclusionBNP or NT-pro-BNP and troponin
Assessing the association between cardiovascular biomarkers in patients with MMVD and survivalduring 5 years after inclusionBNP or NT-pro-BNP and troponin, vital status
Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survivalduring 5 years after inclusionBNP or NT-pro-BNP and troponin, Survival without cardiovascular event
Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional)at baselineBiobank (optional)

Countries

France

Contacts

CONTACTThéo PEZEL
multivalve@sfcardio.fr01 44 90 70 28
CONTACTAugustin COISNE
multivalve@sfcardio.fr01 44 90 70 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026