The Multicenter Cardiology Monitoring Platform Registry

Study Overview
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Brief Summary
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The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is a prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). It's objective is to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.

Detailed Description
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Rationale: Heart failure (HF) represents a heterogeneous range of clinical overlapping cardiomyopathy phenotypes, resulting from multifactorial environmental insults in the presence or absence of a genetic predisposition. A better understanding of (early) cardiomyopathy phenotypes, related cardiovascular diseases, their underlying pathophysiological processes, and their related disease burden is key to pave the way for novel preventive and/or intervention studies. Objective: To optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes. Study design: The multicenter Cardiology Monitoring Platform registry (mCMP-registry) is an investigator-initiated multicentre prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). Study population: All subjects aged ≥16 years that have been referred to the cardiology or genetics department for cardiac symptoms, cardiac screening or cardiogenetic screening are eligible for inclusion. Main study parameters/endpoints: This is a prospective registry from which multiple research questions can be answered. In general, two main approaches will be used: (A) a data-driven (multi-)omics approach which aims to identify clusters of patients to predict clinical outcome, to improve (early) diagnosis, and/or to identify clusters of patients that share underlying pathophysiological processes; (B) a hypothesis-driven approach in which clinical parameters are tested for their (incremental) diagnostic and/or prognostic value.

Official Title
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The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)

Conditions
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Heart Failure, Cardiomyopathies, Atrial Fibrillation, Ventricular Arrythmia, Coronary Artery Disease, Ventricular Tachycardia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines(3)) or for cardiac/cardiogenetic screening; Age ≥16 years. Exclusion Criteria: Unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consenting participants<br>All subjects aged ≥16 years referred to the cardiology or genetic department for heart failure like symptoms (as stated in the ESC 2016 Guidelines) or for cardiac/cardiogenetic screening. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (sudden) cardiac death or heart transplantation | Death attributed to a cardiac cause or sudden, or heart transplantation. | through study completion, an average of 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure hospitalization | Hospitalization due to cardiac decompensation or prolonged hospitalization due to cardiac decompensation | through study completion, an average of 15 years | 
| Life-threatening arrhythmias | justified implantable cardioverter-defibrillator shock, justified anti-tachypacing therapy, cardiac arrest, hemodynamic unstable ventricular tachycardia | through study completion, an average of 15 years | 
| Quality of life EQ-5D questionnaire | EQ-5D questionnaire | through study completion, an average of 15 years | 
| Economic burden | institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) and iMTA Medical Consumption Questionnaire (iMCQ) | through study completion, an average of 15 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, registry, cardiomyopathy, atrial fibrillation, ventricular tachycardia, coronary artery disease