Who may be eligible for the Ultrasound Therapy In Cardiac Amyloidosis trial?

Inclusion Criteria: * 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: \ 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 Criteria: * 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: o Patients with known or suspected Right-to-left, bi-directional, or transient right-to-left cardiac shunts, Hypersensitivity to perflutren * 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

ClinicalTrials.gov record NCT04667494

Ultrasound Therapy In Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Ultrasound Therapy In Cardiac Amyloidosis

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 4A study of a treatment that is already approved, to learn more about its long-term effects, safety or use in everyday practice.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old to 90 years old

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective pilot interventional study testing high‑mechanical‑index ultrasound therapy (sonotherapy) in people with cardiac amyloidosis and in a small control group. About 70 participants are planned: 30 with AL cardiac amyloidosis, 30 with ATTR cardiac amyloidosis, and 10 without amyloidosis. The study measures myocardial blood flow and heart function before and after sonotherapy using PET and echocardiography.

What it is studying. The study tests whether ultrasound therapy given with an intravenous Definity contrast agent changes myocardial blood flow and measures of systolic and diastolic function using PET perfusion and echocardiography in people with AL or ATTR cardiac amyloidosis and in control subjects.

What the researchers hope to learn. To measure the effects of sonotherapy on myocardial blood flow, systolic function (global longitudinal strain), and diastolic function (mitral e' velocity) and to compare findings across AL, ATTR, and control groups.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Combination product: Sonotherapy

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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 criteria

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:
o Patients with known or suspected Right-to-left, bi-directional, or transient right-to-left cardiac shunts, Hypersensitivity to perflutren
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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

70 subjects will be enrolled in this study in 3 study groups: A) 30 subjects with light chain cardiac amyloidosis B) 30 subjects with transthyretin cardiac amyloidosis and C) 10 subjects without amyloidosis. All subjects will undergo rest 2D echocardiography, rest N-13 ammonia or rubidium-82 perfusion PET, Definity infusion with high mechanical index (MI) imaging defined as sonotherapy in this study protocol.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After screening and consent, participants will have baseline heart imaging: a resting 2‑D echocardiogram and a PET perfusion scan (N‑13 ammonia or rubidium‑82). They will receive an intravenous Definity contrast infusion and undergo high mechanical‑index ultrasound imaging (called sonotherapy), with cardiac imaging repeated to measure myocardial blood flow, systolic function (global longitudinal strain) and diastolic function (mitral e' velocity) before and after sonotherapy. All participant groups (AL, ATTR, and controls) undergo the same imaging and sonotherapy procedures.

How the study is structured. Interventional, single-group, open-label pilot study: all participants receive sonotherapy (high mechanical index ultrasound with Definity). Tests (rest echocardiography, PET perfusion) are done before and after the procedure to compare cardiac blood flow and function. Participants are grouped as AL amyloidosis, ATTR amyloidosis, or non-amyloidosis controls.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Aug 31, 2023
Primary completion: Apr 30, 2027 (estimated)
Study completion: Apr 30, 2027 (estimated)
Target enrollment: 70 participants (estimated)
Last updated on registry: Aug 21, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Brigham and Women's Hospital
Principal investigator: Sharmila Dorbala, Director, Nuclear Cardiology
Brigham and Women's Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Sharmila Dorbala, MD 📞 617-732-6290 ✉ sdorbala@bwh.harvard.edu

Participating sites (1)

Brigham and Women's HospitalRecruiting
Boston, Massachusetts, 02115 · United States
- Sharmila Dorbala, MBBS, MPH · 617-732-6290 · sdorbala@partners.org
- Sharmila Dorbala, MBBS, MPH

Terms used on this page · explanations by MedicalUpdates.ai

serum free light chain: Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
biopsy: Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
biomarkers: Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
echocardiogram: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Contraindications: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
QTc: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
PET: A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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