Molecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL Amyloidosis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Fondazione IRCCS Policlinico San Matteo
RECRUITING
Pavia
Contact Information
Primary
Giovanni Palladini, MD, PhD
segreteria.amiloidosi@smatteo.pv.it
+390382502994
Backup
Anna Carnevale Baraglia
a.carnevalebaraglia@smatteo.pv.it
+390382502994
Time Frame
Start Date: 2020-07-22
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 69
Treatments
Experimental: 18F-florbetaben PET-CT scans
Related Therapeutic Areas
Sponsors
Leads: Fondazione IRCCS Policlinico San Matteo di Pavia

This content was sourced from clinicaltrials.gov