Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Launched by UNIVERSITY OF EDINBURGH · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial, called I-CARE, is studying a heart condition known as transthyretin amyloid cardiomyopathy (ATTR-CM). This disease affects the heart muscle, making it difficult for the heart to work properly. As more people age, ATTR-CM is becoming more common, and if left untreated, it can lead to serious health issues. The trial aims to improve how we monitor treatments for this condition using a new imaging technique called 18F-fluoride PET, which may help doctors understand how well treatments are working for different patients.

To participate in this trial, you must be over 40 years old and have been diagnosed with either ATTR or AL amyloidosis, or hypertrophic cardiomyopathy (a condition where the heart muscle becomes too thick). Participants will undergo imaging tests and receive treatment, with the goal of tracking how the disease progresses and how well the treatment works. It’s important to note that certain individuals, such as those with severe heart failure or specific health issues, will not be eligible to join. If you or a loved one is interested, the study is currently recruiting participants, and they will receive detailed information about what to expect throughout the process.

Gender

ALL

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