MULTIVALVE : A Prospective Multicentre Study of Multiple and Mixed Valvular Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with a diagnosis of MMVD
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.
结局指标
主要结局
To assess the association between cardiovascular imaging parameters (echocardiography and cardiac MRI) and cardiovascular event-free survival in a population of MMVD.
时间窗: 1 year after inclusion
Survival without cardiovascular event
次要结局
- Assessing the association between cardiovascular biomarkers in patients with MMVD and cardiovascular event-free survival(during 5 years after inclusion)
- Exploring the value of cardiovascular biomarkers analysed in a centralised laboratory (optional)(at baseline)
- % of patients with MMVD combinations(during 5 years after inclusion)
- Assessing the association between cardiovascular biomarkers in patients with MMVD and survival(during 5 years after inclusion)
- Measurement of cardiovascular biomarkers(at baseline and 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 association between cardiovascular imaging parameters and survival(at 1, 2, 3, 4 and 5 years after inclusion)
- Proportion of patients who did not experience a cardiovascular event(at 1, 2, 3, 4 and 5 years after inclusion)
- Proportion of patients who are alive(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)(at 1, 2, 3, 4 and 5 years after inclusion)
- To assess the progression of the stage of severity of valvulopathy(at 1, 2, 3, 4 and 5 years after inclusion)