Sound waves aim to boost heart health in amyloidosis patients
NCT ID NCT04667494
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This study tests whether a special ultrasound treatment, combined with a contrast agent, can improve blood flow and heart function in people with cardiac amyloidosis. Researchers will measure changes using PET scans and echocardiograms. The trial includes 70 participants with and without amyloidosis to see how the therapy affects the heart.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sonotherapy (high mechanical index ultrasound with intravenous Definity contrast)
- What this could lead to
- If it works, this could point toward a non-invasive way to improve heart blood flow and function in people with cardiac amyloidosis.
- What could go wrong
- This is a small early pilot study with only 70 participants, so results may not apply widely. The therapy is experimental and risks are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Triple-Drug combo tame a rare heart disease?
- Heart imaging may reveal hidden clues in rare heart disease
- Hidden heart risk: study aims to catch deadly protein buildup before symptoms start
- New heart scan could speed up amyloidosis diagnosis