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Ultrasound Therapy for Cardiac Amyloidosis

This study is testing a treatment called sonotherapy, which uses high mechanical index ultrasound with an intravenous (given through a vein) Definity contrast infusion. It's for people with cardiac amyloidosis (a condition where abnormal proteins build up in the heart) and also includes a control group without amyloidosis. The study aims to see if sonotherapy changes myocardial blood flow (blood flow to the heart muscle), and how well the heart pumps (systolic and diastolic function). You could be eligible if you are between 18 and 90 years old, have light chain cardiac amyloidosis and are in hematological remission (normal blood levels of certain proteins), or if you are over 65 with transthyretin cardiac amyloidosis or over 65 for the control group. The study is currently unclear on its recruitment status.

Study design
This is a pilot study planning to enroll 70 participants across three groups: 30 with light chain cardiac amyloidosis, 30 with transthyretin cardiac amyloidosis, and 10 without amyloidosis.
What's involved
You would undergo rest 2D echocardiography (an ultrasound of the heart), rest N-13 ammonia or rubidium-82 perfusion PET (imaging tests), and receive Definity infusion with high mechanical index imaging.
Compensation
Not stated in the trial record.
Follow-up
Myocardial blood flow, systolic function, and diastolic function will be measured at 1 day after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04667494

Ultrasound Therapy In Cardiac Amyloidosis

Recruiting
PHASE4Ages 18–90InterventionalTreatment
Brigham and Women's Hospital
~70 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Sonotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Myocardial Blood Flow
Measured over 1 day
+2 more outcomes measured

Conditions

Amyloidosis Cardiac

Explore related trials

Cardiac Amyloidosis

NCT04667494

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sharmila Dorbala, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Sharmila Dorbala, MD
[email protected]
617-732-6290
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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)
Severe valve stenosis or regurgitation in the aortic, mitral or tricuspid valves, including prior valve replacement
Severe pulmonary artery hypertension
Severe lung disease
Known obstructive epicardial coronary artery disease with stenosis \> 50% in any single territory
Prior cardiac surgery
Regional wall motion abnormality on echocardiogram
Left ventricular ejection fraction \< 40%
Pregnant state
Documented allergy to N-13 ammonia or Definity
Contraindications to DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension:
Contraindications or challenges to sonotherapy
Severe electrolyte abnormalities
QTc prolongation (values are greater than 450 milliseconds in males and greater than 470 milliseconds in females)
BMI \> 35 kg/m2
Documented intracardiac thrombus
Atrial fibrillation not on anticoagulation
Prior history of stroke
Any other reason determined by the investigator that makes a subject a poor candidate for ultrasound therapy

What this trial measures

  • Myocardial Blood Flow1 day

    N-13 ammonia or Rubidium-82 PET based measure of myocardial blood flow in ml/gm/min

  • Systolic Function1 day

    Global Longitudinal Strain by echocardiography

  • Diastolic Function1 day

    Echo measured mitral e' velocity