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New treatment option for Amyloidosis Cardiac
Official title Ultrasound Therapy In Cardiac Amyloidosis
ClinicalTrials.gov ID: NCT04667494
What this study is testing
What is Sonotherapy?
Sonotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for amyloidosis cardiac.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- proof of cardiac involvement by AL amyloidosis
You likely can't join if
- 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
See the full eligibility 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...
- 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: \...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.