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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD. [Срок оценки: 1 year after inclusion]

Вторичные конечные точки (11)

• To assess the association between cardiovascular imaging parameters and survival [Срок оценки: at 1, 2, 3, 4 and 5 years after inclusion]
• Proportion of patients who did not experience a cardiovascular event [Срок оценки: at 1, 2, 3, 4 and 5 years after inclusion]
• Proportion of patients who are alive [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: at 1, 2, 3, 4 and 5 years after inclusion]
• To assess the progression of the stage of severity of valvulopathy [Срок оценки: at 1, 2, 3, 4 and 5 years after inclusion]
• % of patients with MMVD combinations [Срок оценки: during 5 years after inclusion]
• Measurement of cardiovascular biomarkers [Срок оценки: at baseline and 1, 2, 3, 4 and 5 years after inclusion]
• Assessing the association between cardiovascular biomarkers in patients with MMVD and survival [Срок оценки: during 5 years after inclusion]
• Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survival [Срок оценки: during 5 years after inclusion]
• Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional) [Срок оценки: at baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 2 центра

• Chu Lille- Hopital Cardiologique — Lille
• Chu Lariboisiere (Aphp) — Paris

Идентификаторы

NCT: NCT07176507 · 2023-A02626-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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