Non-Compaction CardiomyopathyNONCOMPACTNCT04424030
International Consortium for Multimodality Phenotyping in Adults With Non-compaction
An observational study of Non-Compaction Cardiomyopathy, run by Stanford University at 5 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Compaction Cardiomyopathy
- What is being tested?
- Echocardiography, Magnetic resonance imaging (MRI) and Computed tomography (CT)
- How many people
- 600 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Jan 2021to 1 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hypertrabeculation of the left ventricle fulfilling echo-based criteria of non-compaction cardiomyopathy
Who may be able to join
- ≥18 years old
- Hypertrabeculation of the left ventricle fulfilling the echo-based Jenni criteria of NCCM
- Clinical cardiac MRI examination performed or planned
Who cannot join
- 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.
- Age <21 years
- Decompensated heart failure, or otherwise clinically unstable
- BMI>40 kg/m2
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- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Stanford University
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Non-Compaction Cardiomyopathy
- Being tested
- Echocardiography, Magnetic resonance imaging (MRI), Computed tomography (CT)
- Keywords
- Echocardiography, Magnetic resonance imaging, Computed tomography, Prognosis, Genetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodality imaging | Patients who have undergone echocardiography and cardiac MRI as part of their clinical management A research cardiac CT scan will be performed in eligible participants Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Magnetic resonance imaging (MRI); Diagnostic Test: Computed tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hard embolic adverse events
Clinical neuro/systemic embolic event by autopsy, imaging or specialist evaluation
Measured: Up to 4 years after enrollment
Incidence of hard arrhythmic adverse events
Sudden death (aborted), appropriate ICD discharge or VT/VF on ECG or rhythm/device monitoring
Measured: Up to 4 years after enrollment
Secondary outcomes (6)
Incidence of hard heart failure related adverse events
Heart failure death, cardiac transplantation or mechanical circulatory support
Measured: Up to 4 years after enrollment
Incidence of composite of hard adverse events
Hard embolic, arrhythmic and heart failure related adverse events (as described above)
Measured: Up to 4 years after enrollment
Incidence of all embolic adverse events
Hard embolic adverse events or transient neurologic event without objective infarction
Measured: Up to 4 years after enrollment
Incidence of all arrhythmic adverse events
Hard arrhythmic adverse events or syncope without recorded arrhythmia
Measured: Up to 4 years after enrollment
Incidence of all heart failure related adverse events
Hard heart failure related adverse events or resynchronization therapy, heart failure hospital admission
Measured: Up to 4 years after enrollment
Incidence of composite of adverse events
All embolic, arrhythmic or heart failure related adverse events (as described above)
Measured: Up to 4 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jan 2021
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Compaction CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, University of Pennsylvania, Erasmus Medical Center, Seoul National University Hospital
- Responsible party
- Principal investigator, Koen Nieman, Stanford University
- Investigators
- Koen Nieman, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424030
- Sponsor's protocol ID
- 56001
- Other IDs
- SSU00099737
- Acronym
- NONCOMPACT
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2020
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets will be created and maintained on a public website in a password-protected area, where the frequency of use of the datasets can be monitored by Stanford and NHLBI.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Consortium for Multimodality Phenotyping in Adults With Non-compaction
- ClinicalTrials.gov ID
- NCT04424030
- Acronym / sponsor ID
- NONCOMPACT / 56001
- Conditions
- Non-Compaction Cardiomyopathy
- Keywords
- Echocardiography, Magnetic resonance imaging, Computed tomography, Prognosis, Genetics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, University of Pennsylvania, Erasmus Medical Center, Seoul National University Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodality imaging | – | Diagnostic Test: Echocardiography, Diagnostic Test: Magnetic resonance imaging (MRI), Diagnostic Test: Computed tomography (CT)Patients who have undergone echocardiography and cardiac MRI as part of their clinical management A research cardiac CT scan will be performed in eligible participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hypertrabeculation of the left ventricle fulfilling echo-based criteria of non-compaction cardiomyopathy
Key inclusion criteria (3 listed)
- ≥18 years old
- Hypertrabeculation of the left ventricle fulfilling the echo-based Jenni criteria of NCCM
- Clinical cardiac MRI examination performed or planned
Key exclusion criteria (10 listed)
- 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.
- Age <21 years
- Decompensated heart failure, or otherwise clinically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyStandard echocardiography exam performed as part of clinical management. | Diagnostic test | Multimodality imaging |
| Magnetic resonance imaging (MRI)Standard comprehensive cardiac MRI exam of the heart performed as part of clinical management. | Diagnostic test | Multimodality imaging |
| Computed tomography (CT)ECG-triggered, contrast-enhanced CT scan of the heart performed for research purposes in eligible study participants. | Diagnostic test | Multimodality imaging |
Primary outcome
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
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
6 secondary outcomes
Incidence of hard heart failure related adverse events
Time frame: Up to 4 years after enrollment
Incidence of composite of hard adverse events
Time frame: Up to 4 years after enrollment
Incidence of all embolic adverse events
Time frame: Up to 4 years after enrollment
Incidence of all arrhythmic adverse events
Time frame: Up to 4 years after enrollment
Incidence of all heart failure related adverse events
Time frame: Up to 4 years after enrollment
Incidence of composite of adverse events
Time frame: Up to 4 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified datasets will be created and maintained on a public website in a password-protected area, where the frequency of use of the datasets can be monitored by Stanford and NHLBI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Nieman, MD, PhD principal investigator
Stanford University
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Compaction Cardiomyopathy, run by Stanford University at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Netherlands, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hard embolic adverse events (time frame: Up to 4 years after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.