Clinical trial NCT04976348: The Multicenter Cardiology Monitoring Platform Registry
Official title: The Multicenter Cardiology Monitoring Platform Registry (mCMP-registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Cardiomyopathies
Atrial Fibrillation
Ventricular Arrythmia
Coronary Artery Disease
Ventricular Tachycardia
Keywords: heart failure
registry
cardiomyopathy
atrial fibrillation
ventricular tachycardia
coronary artery disease
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Zuyderland Medical Centre
First posted: 2021-07-26
Enrollment: 40000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: (sudden) cardiac death or heart transplantation
timeFrame: through study completion, an average of 15 years
Secondary outcomes:
measure: Heart Failure hospitalization
timeFrame: through study completion, an average of 15 years
measure: Life-threatening arrhythmias
timeFrame: through study completion, an average of 15 years
measure: Quality of life EQ-5D questionnaire
timeFrame: through study completion, an average of 15 years
measure: Economic burden
timeFrame: through study completion, an average of 15 years
Other outcomes:
measure: Age
timeFrame: through study completion, an average of 15 years
measure: Sex
timeFrame: through study completion, an average of 15 years
measure: Body mass index
timeFrame: through study completion, an average of 15 years
measure: Underlying pathogenic
timeFrame: through study completion, an average of 15 years
measure: Medication usage
timeFrame: through study completion, an average of 15 years
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Hans-Peter Brunner-La Rocca, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henkens MTHM, Weerts J, Verdonschot JAJ, Raafs AG, Stroeks S, Sikking MA, Amin H, Mourmans SGJ, Geraeds CBG, Sanders-van Wijk S, Barandiaran Aizpurua A, Uszko-Lencer NHMK, Krapels IPC, Wolffs PFG, Brunner HG, van Leeuwen REW, Verhesen W, Schalla SM, van Stipdonk AWM, Knackstedt C, Li X, Abdul Hamid MA, van Paassen P, Hazebroek MR, Vernooy K, Brunner-La Rocca HP, van Empel VPM, Heymans SRB. Improving diagnosis and risk stratification across the ejection fraction spectrum: the Maastricht Cardiomyopathy registry. ESC Heart Fail. 2022 Apr;9(2):1463-1470. doi: 10.1002/ehf2.13833. Epub 2022 Feb 4.