mCMP-registry: The Maastricht Cardiomyopathy Registry
Study Details
Study Description
Brief Summary
The Maastricht cardiomyopathy registry (mCMP-registry) is an 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) cardiomyopathy phenotypes and to create a better understanding of underlying pathophysiological processes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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, 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) cardiomyopathy phenotypes and to create a better understanding of underlying pathophysiological processes.
Study design: The Maastricht cardiomyopathy registry (mCMP-registry) is an investigator-initiated single center (Maastricht University Medical Center, MUMC+) 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 referred to the cardiology outpatient clinic of the MUMC+ for heart failure like symptoms (as stated in the ESC 2016 Guidelines) and/or for cardiac 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Consenting participants All subjects aged ≥16 years referred to the cardiology outpatient clinic of the MUMC+ for heart failure like symptoms (as stated in the ESC 2016 Guidelines) and/or for cardiac screening are eligible for inclusion. |
Outcome Measures
Primary Outcome Measures
- (sudden) cardiac death or heart transplantation [through study completion, an average of 15 years]
Secondary Outcome Measures
- Heart Failure hospitalization [through study completion, an average of 15 years]
- Life-threatening arrhythmias [through study completion, an average of 15 years]
justified implantable cardioverter-defibrillator shock, justified anti-tachypacing therapy, cardiac arrest, hemodynamic unstable ventricular tachycardia
- Quality of life EQ-5D questionnaire [through study completion, an average of 15 years]
EQ-5D questionnaire
- Economic burden [through study completion, an average of 15 years]
institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ) and iMTA Medical Consumption Questionnaire (iMCQ)
Other Outcome Measures
- Age [through study completion, an average of 15 years]
- Sex [through study completion, an average of 15 years]
- Body mass index [through study completion, an average of 15 years]
- Underlying pathogenic [through study completion, an average of 15 years]
variants found in cardiac associated genes
- Medication usage [through study completion, an average of 15 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Referred to the cardiology outpatient clinic of the MUMC+ for heart failure like symptoms (as stated in the ESC 2016 Guidelines(3)) or for cardiac screening;
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maastricht UMC+ | Maastricht | Limburg | Netherlands | 6229HX |
Sponsors and Collaborators
- Maastricht University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL76585.068.21