Recruiting

Ultrasound Therapy

Sponsor:

Brigham and Women's Hospital

Code:

NCT04667494

Conditions

Amyloidosis Cardiac

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Sonotherapy

Study Details

Brief 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.

Conditions

Amyloidosis Cardiac

Study ID

NCT04667494

Start date

Aug 31, 2023

Status verified date

Aug, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sonotherapy

All participants will undergo sonotherapy

Interventions

Sonotherapy

Use of high mechanical index ultrasound therapy with intravenous Definity contrast infusion

Primary outcome measure

  • Myocardial Blood Flow [ Time Frame: 1 day ]
  • Systolic Function [ Time Frame: 1 day ]
  • Diastolic Function [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sharmila Dorbala, MBBS, MPH

617-732-6290sdorbala@partners.org

Principal Investigator:

Sharmila Dorbala, MBBS, MPH

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-08-21.