Molecular Imaging of Primary Amyloid Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorBrigham and Women's Hospital
About this trial
Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments.
Eligibility criteria
Qualifiers
Age > 18 years
Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed)
For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study.
Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D.
Disqualifiers
Hemodynamic instability
Decompensated heart failure (unable to lie flat for 1 hour)
Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
Known obstructive epicardial coronary artery disease with stenosis > 50% in any single territory
Trial design
Treatments tested in this trial
- F-18 florbetapir/C-11 acetate PET
- MRI
- N-13 ammonia PET
Treatment groups
171 Participants
are divided into 5 treatment groupsLocations
1Brigham and Womens' Hospital02421, BostonMassachusetts, United States
Sponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
American Heart Association
Collaborator
Source ClinicalTrials.gov