European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

Aortic Valve Stenosis Clinical Trial

— EACVI-MMVD  

Official title:

European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235385
• Other study ID #: AP-HP : 231784
• Status: Recruiting
• Start date: February 7, 2024
• Est. completion date: August 1, 2029

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Théo PEZEL, MD PhD
• Phone: 668722489
• Email: theo.pezel[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.

Description:

Multiple and mixed valvular heart disease (MMVD), ie, the combination of stenotic or regurgitant lesions occurring on ≥2 cardiac valves (multiple valvular heart disease (VHD)) or the combination of stenotic and regurgitant lesions on the same valve (mixed VHD), are frequent in clinical routine. Nevertheless, their clinical, biological, cardiovascular imaging, and management is not well established.

This study will assess the proportion of MMVD including each combination of multiple and mixed VHD in a multicentre registry of all consecutive patients assessed on a cardiovascular imaging department for VHD. Furthermore, as secondary aims, baseline characteristics, decision-making and therapeutic strategy at baseline and their impact in terms of prognostic.

This is a prospective multicentre observational study involving 174 centres worldwide (35 countries) conducted as a cohort study with a 1-year follow-up (with possible extension to 5 years). Consecutive patients with a diagnosis of MMVD by echocardiography who meet the inclusion criteria will be included during the 6 months period of recruitment. In the context of a "real-life" cohort, baseline evaluation will be left to the discretion of the attending physician (and could encompass clinical evaluations, biomarkers, electrocardiograms, transthoracic and transoesophageal echocardiography, stress echocardiography, cardiac catheterization, invasive angiography, cardiac CT, and Cardiac MRI). Final diagnosis of the physician will be given, and physician will manage the patient in accordance with international guidelines (transcatheter valve intervention, surgery or no intervention). One year follow-up will be performed during a patient visit or by contact with the treating physician or the patient: vital status, hospitalizations for cardiac reasons (including heart failure), history of stroke and the performance of a new valvular intervention.

The primary endpoint will be the proportion of MMVD among all patients admitted for VHD evaluation in the imaging department. Secondary endpoints encompass; (i) epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline. (ii) proportion of MMVD treated by surgery, percutaneous or medical as well as the detail for management and how complication are managed (iii) prognostic evaluation at one year of follow-up in terms of clinical composite outcome (cardiovascular mortality, hospitalization for heart failure, myocardial infarction, pulmonary embolism and stroke), all-cause mortality, hospitalisation for heart failure, and change in echocardiographic parameters.

This is the first prospective multicentre study assessing the proportion of MMVD and their characteristics in term of diagnosis, management, and prognostic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 1, 2029
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Patient referred to the cardiovascular imaging department.

3. Diagnosis of MMVD confirmed by transthoracic echocardiography, defined as:

1. Multiple VHD: at least 2 moderates to severe VHD involving = 2 different valves, using the current ESC guidelines.

and/or

2. Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve, using the current ESC guidelines.

4. Patient not refusing to have their data involved in the protocol after information.

Exclusion Criteria (patients fulfilling any of the following criteria are not eligible for inclusion in this study):

1. History of prior valve surgery or percutaneous valve intervention (concerning a valve other than those involved in the definition of MMVD).

2. Acute infective endocarditis at the time of evaluation for inclusion (confirmed according to modified Duke criteria) or history of endocarditis = 6 months.

3. Complex congenital heart diseases.

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Aortic Valve Stenosis With Insufficiency
• Constriction, Pathologic
• Heart Valve Diseases
• Mitral Valve Disease
• Mitral Valve Insufficiency
• Mitral Valve Stenosis
• Tricuspid Valve Disease
• Tricuspid Valve Insufficiency

Intervention

Other:
• Intervention not provided
This study is purely observational

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Paris	Paris	Île De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	European Association of Cardiovascular Imaging

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of multiple and mixed valvular disease (MMVD)	Number of consecutive patients diagnosed with multiple and mixed valvular disease divided by the total number of consecutive patients assessed for valvular heart disease on a cardiovascular imaging department	Baseline
Secondary	Major Adverse Cardiovascular Event (MACE)	Clinical composite outcome defined as: cardiovascular mortality, hospitalization for heart failure (HF), myocardial infarction, pulmonary embolism and stroke.	Up to 5 years
Secondary	All-cause mortality	The adjudication of all-cause death was performed using the follow-up performed in clinical routine	Up to 5 years
Secondary	Cardiovascular mortality	The adjudication of cardiovascular mortality was performed using the follow-up performed in clinical routine	Up to 5 years
Secondary	Hospitalization for heart failure	Hospitalization for heart failure according to the European Society of Cardiology (ESC) guidelines	Up to 5 years