Status:
RECRUITING
Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
AL Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This will be a systematic, combined, prospective assessment of the novel echographic, CMR, and PET imaging tools in newly-diagnosed patients with cardiac AL amyloidosis at baseline and after treatment...
Eligibility Criteria
Inclusion
- 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
- non-AL amyloidosis;
- NYHA class IV;
- PS-ECOG \>3;
- severe allergy to paramagnetic tracer;
- severe claustrophobia;
- pregnant or nursing women;
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT04392960
Start Date
July 22 2020
End Date
June 30 2025
Last Update
May 7 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100