Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT07110818
Eligibility Criteria:
Inclusion Criteria:
1. LVEF \<50% and/or
2. LVEF 50-55% with presence of clinically significant late gadolinium enhancement or LV dilatation and being carrier of a non ischemic cardiomyopathy causing gene (Pathogenic or likely pathogenic variant in a Clingen moderate or definite gene)
Exclusion Criteria:
* A significant other cause of decreased LVEF such as:
1. Coronary artery stenosis (Significant lesion on proximal Left anterior descending or Left main, or ≥2 main branches with stenosis. Significant lesion is defined as \>70% of any artery or \>50% for the left main artery) or prior history of type 1 myocardial infarction
2. Significant congenital heart disease requiring intervention
3. Primary valvular disease including moderate to severe aortic stenosis and moderate to severe mitral stenosis, primary severe mitral regurgitation (secondary valvular disease such as mitral regurgitation/tricuspid regurgitation are not exclusion criteria)
4. Other distinct entities: Amyloid heart disease, Chagas, Takotsubo, sarcoidosis, hemochromatosis related cardiomyopathy, HIV related cardiomyopathy are excluded
5. Substances/therapies induced cardiomyopathy only if they are deemed to be the sole explanation for the cardiomyopathy (at the discretion of the enrolling cardiologist)
6. Clear history of burned out hypertrophic cardiomyopathy
7. Already had a transplantation at time of first CMR
8. Refusal to provide informed consent
Additional remarks:
Patients aged \> 70 years of age at first contact with a cardiologist regarding the cardiomyopathy will be limited to maximum 10% of the total enrolled patients by center.
Patients with risk factors (for example, chemotherapy, radiotherapy, alcohol…) for cardiomyopathy are not excluded unless they are deemed to completely account for the phenotype per the treating physician.
The inclusion is not restricted to adult patients and is planned to be extended to the pediatric population.
All included patients are recommended to have a CMR performed within 3 years of inclusion.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT07110818
Study Brief:
Protocol Section:
NCT07110818