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NCT Number: NCT04424030

International Consortium for Multimodality Phenotyping in Adults With Non-compaction

Non-compaction cardiomyopathy (NCCM) is a heterogeneous, poorly understood disorder characterized by a prominent inner layer of loose myocardial tissue, and associated with heart failure, stroke, severe rhythm irregularities and death. For a growing population diagnosed with NCCM there is a need for better risk stratification to appropriately allocate (or safely withhold) these impactful preventive measures. The goal of this international consortium is to improve care of patients with non-compaction cardiomyopathy. We hypothesize that comprehensive analysis of clinical, genetic, structural and functional information will improve risk stratification. In addition, we hypothesize that detailed structural analysis will allow for differentiation of pathological and benign patterns of non-compaction. In a large cohort of adult patients with suspected NCCM we will perform in-depth phenotyping, including clinical information, pedigree data, genetics, echocardiography and MRI, and follow patients for up to 3 years. We will apply machine-learning based analytics to develop predictive models and compare their performance to currently used models and treatment criteria. Secondly, in a subset of patients we will perform high-resolution cardiac CT for detailed structural characterization of the myocardial wall. We will investigate associations between myocardial structure and regional contractile function, as assessed by echo and MRI. The aim of this proposal is to identify a structural signature associated with pathological non-compaction and improve developed risk prediction models. Discovery of pathological structural signatures through innovative imaging techniques, in relation to myocardial contractility, will advance our understanding of NCCM.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Non-Compaction Cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus Medical Center, Rotterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • Hypertrabeculation of the left ventricle fulfilling the echo-based Jenni criteria of NCCM
  • Clinical cardiac MRI examination performed or planned

Exclusion criteria

(general cohort):

  • Complex congenital disease (including transposition great arteries, tetralogy of Fallot, tricuspid atresia, truncus arteriosis, single ventricle, hypoplastic left heart, pulmonary atresia, double-outlet RV), neuromuscular disorders or isolated RV non-compaction
  • Inability to provide informed consent
  • Contra-indications to MRI, which apply if the clinical cardiac MRI has not yet been performed at the time of study enrollment: permanent pacemakers/ICDs, MRI contrast medium allergy, significant arrhythmia with highly irregular RR intervals, severe dyspnea with inability to lay flat/breath hold, inability to communicate with the MRI technician or follow commands for any reason (psychosis, agitation, etc.), other site-specific contra-indications to clinical MRI of the heart.

Exclusion criteria

(cardiac CT examination):

  • Age <21 years
  • Decompensated heart failure, or otherwise clinically unstable
  • BMI>40 kg/m2
  • Pregnancy (or cannot be ruled out)
  • Known iodine contrast medium allergy
  • Kidney dysfunction: eGFR<45 ml/min
  • Thyroid disease: toxic multinodular goiter, Graves' disease, Hashimoto's thyroiditis

Treatment and study plan

Echocardiography

Diagnostic Test

Standard echocardiography exam performed as part of clinical management.

Magnetic Resonance Imaging (MRI)

Diagnostic Test

Standard comprehensive cardiac MRI exam of the heart performed as part of clinical management.

Computed Tomography (CT)

Diagnostic Test

ECG-triggered, contrast-enhanced CT scan of the heart performed for research purposes in eligible study participants.

Primary outcomes

  1. Incidence of hard embolic adverse events

    Time frame: Up to 4 years after enrollment

    Clinical neuro/systemic embolic event by autopsy, imaging or specialist evaluation

  2. Incidence of hard arrhythmic adverse events

    Time frame: Up to 4 years after enrollment

    Sudden death (aborted), appropriate ICD discharge or VT/VF on ECG or rhythm/device monitoring

Secondary outcomes

  1. Incidence of hard heart failure related adverse events

    Time frame: Up to 4 years after enrollment

    Heart failure death, cardiac transplantation or mechanical circulatory support

  2. Incidence of composite of hard adverse events

    Time frame: Up to 4 years after enrollment

    Hard embolic, arrhythmic and heart failure related adverse events (as described above)

  3. Incidence of all embolic adverse events

    Time frame: Up to 4 years after enrollment

    Hard embolic adverse events or transient neurologic event without objective infarction

  4. Incidence of all arrhythmic adverse events

    Time frame: Up to 4 years after enrollment

    Hard arrhythmic adverse events or syncope without recorded arrhythmia

  5. Incidence of all heart failure related adverse events

    Time frame: Up to 4 years after enrollment

    Hard heart failure related adverse events or resynchronization therapy, heart failure hospital admission

  6. Incidence of composite of adverse events

    Time frame: Up to 4 years after enrollment

    All embolic, arrhythmic or heart failure related adverse events (as described above)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Erasmus Medical Center
  • Seoul National University Hospital
  • The Cleveland Clinic
  • University of Pennsylvania

Registry information

Acronym: NONCOMPACT

Important dates

Study start
2021
Primary completion
2027
Study completion
2030
First posted
Jun 9, 2020
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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