Actively Recruiting
Intracardiac Flow Assessment in Cardiac Amyloidosis
Led by Mayo Clinic · Updated on 2025-07-14
100
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to define the intracardiac flow imaging biomarkers in cardiac amyloidosis.
CONDITIONS
Official Title
Intracardiac Flow Assessment in Cardiac Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is clinically stable without cardiovascular-related hospitalizations within 6 weeks prior to enrollment
- Subject is able to provide written informed consent and willing to complete study procedures
- Currently in sinus rhythm by clinical assessment or documented electrocardiographic studies
- Healthy control volunteers must have Karnofsky performance scale > 80% and ECOG status 0 or 1
- ATTR cardiac amyloidosis diagnosed within 5 years; no AL, heavy chain disease, multiple myeloma, or malignant lymphoproliferative disorders; with confirmed transthyretin amyloid deposits and cardiac involvement by imaging or biopsy
- AL amyloidosis with cardiac involvement diagnosed within 5 years, with histopathologic diagnosis, clinical signs of heart failure, and cardiac involvement confirmed by biopsy or imaging
- AL amyloidosis without cardiac involvement diagnosed within 5 years, with histopathologic diagnosis, no heart failure signs, and absence of cardiac involvement by imaging or biomarkers
You will not qualify if you...
- Unable to consent or complete all study procedures
- Unable to walk for 6 minutes
- Unable to lie flat on back for 30 minutes
- Unable to hold breath for 10 seconds
- Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
- Presence of implantable cardiac pacemaker or defibrillator
- History of complex congenital heart disease, intracardiac shunt (except patent foramen ovale), prosthetic valves, or prosthesis in major arteries
- Significant artifact from prior MRI studies
- Pregnant or breastfeeding women
- Weight ≥ 155 kg or body diameter ≥ 70 cm
- Documented non-sinus rhythm within 1 week prior to screening
- Healthy controls excluded if history of cardiomyopathy, structural heart disease, significant valvular disease, coronary artery disease, cardiac surgery, arrhythmias, left ventricular hypertrophy, kidney disease, uncontrolled hypertension, use of multiple medications for hypertension or diabetes, history of stroke, current smoking, plasma cell dyscrasia, malignant hematologic diagnosis, or BMI > 35 kg/m²
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
K
Kathy Brown
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here