Ultrasound Therapy In Cardiac Amyloidosis

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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

⁃ proof of cardiac involvement by AL amyloidosis

⁃ abnormal cardiac biomarkers (Abnormal high sensitivity TnT 5th generation levels (\>9 ng/L: female, \>14 ng/L: male) or abnormal age appropriate N terminal pro-brain natriuretic peptide, NT-proBNP (abnormal values: \<50 years: \>450 pg/ml; 50-75 years:\>900 pg/ml; \>75 years: \>1800 pg/ml) or

⁃ abnormal echocardiogram (wall thickness \> 12 mm) or

⁃ abnormal cardiac MRI (wall thickness \> 12 mm or extracellular volume \> 0.35) OR

• Diagnosis of transthyretin cardiac amyloidosis by standard criteria

‣ endomyocardial biopsy followed by typing of the transthyretin amyloidosis using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed

⁃ extracardiac biopsy with typical cardiac imaging findings, or

⁃ grade 2 or grade 3 myocardial uptake of technetium-99m pyrophosphate (PYP) if AL amyloidosis is excluded

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Sharmila Dorbala, MD
sdorbala@bwh.harvard.edu
617-732-6290
Time Frame
Start Date: 2023-08-31
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 70
Treatments
Experimental: Sonotherapy
All participants will undergo sonotherapy
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov