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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sonotherapy
Combination productUse of high mechanical index ultrasound therapy with intravenous Definity contrast infusion
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: SonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Myocardial Blood Flow
N-13 ammonia or Rubidium-82 PET based measure of myocardial blood flow in ml/gm/min
Time frame
1 day2
Systolic Function
Global Longitudinal Strain by echocardiography
Time frame
1 day3
Diastolic Function
Echo measured mitral e' velocity
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov