Actively Recruiting
Ultrasound Therapy In Cardiac Amyloidosis
Led by Brigham and Women's Hospital · Updated on 2025-11-14
70
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ultrasound Therapy In Cardiac Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years for light chain cardiac amyloidosis, > 65 years for transthyretin cardiac amyloidosis, and > 65 years for controls
- Willing and able to provide consent
- Diagnosis of systemic light chain amyloidosis by standard criteria and in hematological remission with normal serum free light chain levels
- Proof of cardiac involvement by light chain amyloidosis confirmed by abnormal cardiac biomarkers or abnormal echocardiogram or abnormal cardiac MRI
- Diagnosis of transthyretin cardiac amyloidosis by standard criteria including biopsy or typical imaging findings or grade 2 or 3 myocardial uptake of technetium-99m pyrophosphate with exclusion of light chain amyloidosis
You will not qualify if you...
- Hemodynamic instability
- Severe claustrophobia despite sedatives
- Decompensated heart failure preventing lying flat for 1 hour
- Concomitant non-ischemic non-amyloid heart disease such as valvular heart disease or dilated cardiomyopathy
- Severe valve stenosis or regurgitation including prior valve replacement
- Severe pulmonary artery hypertension
- Severe lung disease
- Known obstructive epicardial coronary artery disease with > 50% stenosis in any territory
- Prior cardiac surgery
- Regional wall motion abnormality on echocardiogram
- Left ventricular ejection fraction less than 40%
- Pregnancy
- Documented allergy to N-13 ammonia or Definity
- Contraindications to Definity including cardiac shunts or hypersensitivity to perflutren
- Contraindications to sonotherapy including severe electrolyte abnormalities, QTc prolongation, BMI over 35 kg/m2, intracardiac thrombus, atrial fibrillation not on anticoagulation, or prior stroke
- Any other investigator-determined reasons making subject a poor candidate for ultrasound therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Sharmila Dorbala, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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