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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT05776212
Eligibility Criteria:
Inclusion Criteria:
* Completion of informed consent
* Age \> 40 years for patients with ATTR or AL cardiac amyloidosis and age \>30 years for patients with HCM
* ATTR cardiac amyloid according to Expert Consensus Recommendations
* AL amyloidosis according to Expert Consensus Recommendations
* Hypertrophic cardiomyopathy according to European Society of Cardiology guidelines
Exclusion Criteria:
* Inability or unwilling to give informed consent
* Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
* Renal dysfunction (eGFR ≤30 mL/min/1.73m2)
* NYHA Class IV heart failure
* Patients with atrial fibrillation and poor rate control.
* Contraindications to MR
* Previous history of contrast allergy of adverse reactions (gadolinium)
* Contraindications to tafamidis therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05776212
Study Brief:
Protocol Section:
NCT05776212