Actively Recruiting
Molecular Imaging of Primary Amyloid Cardiomyopathy
Led by Brigham and Women's Hospital · Updated on 2025-11-14
171
Participants Needed
1
Research Sites
665 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments.
CONDITIONS
Official Title
Molecular Imaging of Primary Amyloid Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Diagnosis of light chain amyloidosis by standard criteria including immunofixation, free light chain assay, biopsy, and typing
- Willing and able to provide consent
- For remission group: Hematological remission or very good partial response with dFLC <40 mg/dL for over 1 year
- For active AL-CMP exercise group: Ability to perform supine bicycle exercise
- For active AL Pre-CMP group: Normal left ventricular wall thickness (≤12 mm) and normal LVEF (≥55%) on echocardiography or increased wall thickness with normal cardiac biomarkers
- For control groups: Diagnosis of multiple myeloma without amyloidosis or heart failure without amyloidosis
- For active AL-CMP group: Abnormal troponin T or age-appropriate NT-proBNP levels according to defined thresholds
You will not qualify if you...
- Hemodynamic instability
- Decompensated heart failure preventing lying flat for 1 hour
- Non-ischemic non-amyloid heart diseases such as valvular heart disease or dilated cardiomyopathy
- Known obstructive coronary artery disease with stenosis over 50%
- Severe claustrophobia despite sedatives
- MRI contraindications including metallic implants except for certain control heart failure subjects
- Significant renal dysfunction with eGFR below 30 ml/min/m2 within 14 days of MRI study
- Subjects on dialysis
- Pregnancy
- Allergy to F-18 florbetapir, C-11 acetate, or gadolinium
- Inability to return for follow-up evaluations at 6 and 12 months (specific to active AL-CMP groups)
- For microbiota study: Hypertrophic cardiomyopathy, HIV or chronic viral hepatitis, inflammatory bowel disease, recent use of systemic antibiotics/antivirals/antifungals/antiparasitic agents within 6 months, inability to mail stool sample timely, bowel surgery, colon cancer, recent chemotherapy, and pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Womens' Hospital
Boston, Massachusetts, United States, 02421
Actively Recruiting
Research Team
S
Sharmila Dorbala, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
5
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