NCT04976348

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for all trials

Timeline
311mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jul 2021Dec 2051

First Submitted

Initial submission to the registry

June 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
30.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2051

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2051

Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

30.4 years

First QC Date

June 22, 2021

Last Update Submit

November 19, 2024

Conditions

Keywords

heart failureregistrycardiomyopathyatrial fibrillationventricular tachycardiacoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • (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 Outcomes (4)

  • Heart Failure hospitalization

    through study completion, an average of 15 years

  • Life-threatening arrhythmias

    through study completion, an average of 15 years

  • Quality of life EQ-5D questionnaire

    through study completion, an average of 15 years

  • Economic burden

    through study completion, an average of 15 years

Other Outcomes (5)

  • 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

  • +2 more other outcomes

Study Arms (1)

Consenting participants

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.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35118823BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, and cardiac biopsy samples

MeSH Terms

Conditions

Heart FailureCardiomyopathiesAtrial FibrillationCoronary Artery DiseaseTachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesTachycardiaCardiac Conduction System Disease

Study Officials

  • Hans-Peter Brunner-La Rocca, Prof.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerremy Weerts, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2021

First Posted

July 26, 2021

Study Start

July 1, 2021

Primary Completion (Estimated)

December 1, 2051

Study Completion (Estimated)

December 1, 2051

Last Updated

November 21, 2024

Record last verified: 2024-11

Locations