Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · May 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying new imaging methods to better understand and monitor cardiac AL amyloidosis, a serious condition where abnormal proteins build up in the heart, affecting its function. The researchers want to see how well these imaging techniques, including echocardiograms, cardiac magnetic resonance (CMR), and positron emission tomography (PET), work in patients who have just been diagnosed. Participants will have their heart condition assessed at the beginning of the study and again after six months of treatment.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of AL amyloidosis with specific heart involvement. They should also have measurable heart and blood issues and be planning to start chemotherapy for their condition. Those who join the study can expect regular check-ups and imaging tests to help track their progress. It’s important to note that individuals with certain conditions, such as severe heart issues or those who are pregnant, cannot participate. This trial aims to enhance how we monitor and treat this complex disease, potentially leading to better outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • age more than 18;
• • histological diagnosis of AL amyloidosis;
• • measurable cardiac involvement as per current response criteria (i.e. NT-proBNP \>650 ng/L);
• • measurable hematologic disease (dFLC \>20 mg/L);
• • adequate renal function (eGFR \>30 mL/min) in order to be safely administered gadolinium;
• • absence of atrial fibrillation with uncontrolled heart rate;
• • absence of implantable cardiac devices;
• • absence of pulmonary amyloidosis histologically documented;
• • plan to start anti-plasma cell chemotherapy;
• • plan to assess response at the Pavia center after 6 months;
• • have given written informed consent to participate.
• Exclusion Criteria:
• • non-AL amyloidosis;
• • NYHA class IV;
• • PS-ECOG \>3;
• • severe allergy to paramagnetic tracer;
• • severe claustrophobia;
• • pregnant or nursing women;