International consortium for better understanding of non-compaction cardiomyopathy
International Consortium for Multimodality Phenotyping in Adults With Non-compaction
This study is trying to better understand non-compaction cardiomyopathy in adults by looking at their heart health and genetics to improve care and prevention for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Trial ID | NCT04424030 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the care of adults diagnosed with non-compaction cardiomyopathy (NCCM) by conducting a comprehensive analysis of clinical, genetic, structural, and functional data. The consortium will perform in-depth phenotyping using echocardiography, magnetic resonance imaging (MRI), and computed tomography (CT) to enhance risk stratification for patients. By differentiating between pathological and benign patterns of non-compaction, the study seeks to provide better preventive measures for this heterogeneous disorder. The research will involve a large cohort of adult patients with suspected NCCM, following them over time to gather valuable data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with hypertrabeculation of the left ventricle meeting specific echocardiographic criteria for NCCM.
Not a fit: Patients with complex congenital heart disease, neuromuscular disorders, or those unable to undergo MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with non-compaction cardiomyopathy.
How similar studies have performed: Other studies have shown promise in using multimodal imaging and genetic analysis for similar cardiac conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California and 4 other locations
- Stanford University — Palo Alto, California, United States (Recruiting)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Koen Nieman, MD, PhD — Stanford University
- Study coordinator: Koen Nieman, MD, PhD
- Email: knieman@stanford.edu
- Phone: 6507237476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.