Ultrasound Therapy In Cardiac Amyloidosis
ConditionAmyloidosis Cardiac
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBrigham and Women's Hospital
About this trial
This is a prospective pilot clinical study of subjects with cardiac amyloidosis and control subjects without amyloidosis where we plan to evaluate changes in myocardial blood flow, systolic and diastolic function before and after sonotherapy.
Eligibility criteria
Qualifiers
Age > 18 years for AL-CA, > 65 years for ATTR-CA, > 65 years for controls
Willing and able to provide consent
Diagnosis of systemic light chain amyloidosis by standard criteria (see below) and in hematological remission (normal serum free light chain levels)
(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) AND
Disqualifiers
Hemodynamic instability
Severe claustrophobia despite use of sedatives
Decompensated heart failure (unable to lie flat for 1 hour)
Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
Trial design
Treatments tested in this trial
- Sonotherapy
Treatment groups
70 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov