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 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT05100420
Eligibility Criteria:
Inclusion Criteria:
Patients with (1) AND/OR (2)
1. Clinical diagnosis of HCM, defined as
1. maximal LVWT ≥15mm, or
2. maximal LVWT ≥13mm, in presence of a diagnosis of first degree relative with HCM, or
3. septal wall thickness with z-score \>2 in a child
AND/OR
2. Carrier of a pathogenic or likely pathogenic genetic variant in a sarcomeric gene (ACTC1, FHOD3, MYBPC3, MYH7, MYL2, MYL3, TNNI3, TNNT2, TPM1). Variant classification should be performed by a certified diagnostic laboratory according to the American College of Medical Genetics and Genomics (ACMG) guidelines.
Exclusion Criteria:
1. Clinical or molecular diagnosis of Noonan syndrome or other Rasopathies
2. Clinical or molecular diagnosis of metabolic disease associated with cardiomyopathy, such as Pompe (GAA), Fabry (GLA), Danon (LAMP2), AMP-kinase (PRKAG2), and carnitine disorders
3. Clinical diagnosis of a neuromuscular disease associated with cardiomyopathy, such as Friedrich's ataxia
4. Clinical diagnosis of cardiac amyloidosis with or without the presence of genetic variants in TTR
5. Clinical or molecular diagnosis of mitochondrial cardiomyopathy
6. Diagnosis of HCM \>65 years old AND absence of pathogenic or likely pathogenic variant in a sarcomeric gene (as defined in inclusion criterion 1B above)
7. History of myocardial infarction
8. History of moderate or severe aortic stenosis
9. History of congenital heart defects requiring percutaneous or surgical correction
10. History of severe hypertension defined as a systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>110 mmHg AND absence of pathogenic or likely pathogenic variant in a sarcomeric gene (as defined in inclusion criterion 1B above)
11. Refusal to provide informed consent or to provide a biospecimen for DNA analysis
12. No possibility to upload transthoracic echocardiogram or cardiac magnetic resonance imaging for core lab interpretation
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05100420
Study Brief:
Protocol Section:
NCT05100420