Actively Recruiting
Intracardiac Flow Assessment in Cardiac Amyloidosis
Led by Mayo Clinic · Updated on 2025-07-14
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying cardiac amyloidosis, a condition affecting the heart, to identify specific imaging markers in the heart's blood flow. This observational study aims to better understand these markers in different types of amyloidosis, including transthyretin (ATTR) and light chain (AL) amyloidosis, as well as in healthy adults without cardiovascular disease. The goal is to define intracardiac flow imaging biomarkers that can help characterize this disease. Participants are grouped based on their diagnosis: those with ATTR cardiac amyloidosis, AL amyloidosis with and without cardiac involvement, and healthy controls. All participants will undergo three diagnostic tests: cardiac magnetic resonance imaging (CMR) to assess heart structure and blood flow, transthoracic echocardiogram (TTE) using ultrasound to image the heart and vessels, and a six-minute walk test to measure exercise capacity. These assessments are designed to provide detailed information on heart function and activity. During the study, participants will complete these imaging tests and exercise assessments, which will help researchers measure the intracardiac flow biomarkers at baseline. The study includes healthy volunteers and individuals aged 40 years and older who are clinically stable. Safety and ability to complete study procedures are monitored, and the primary outcome is the identification of intracardiac flow imaging markers related to cardiac amyloidosis. The study is expected to continue until June 2026.
CONDITIONS
Brief Title
Intracardiac Flow Assessment in Cardiac Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Clinically stable without cardiovascular-related hospitalizations within 6 weeks prior to enrollment
- Able to provide written informed consent and complete study procedures
- Currently in sinus rhythm confirmed by clinical or electrocardiographic assessment
- Healthy controls must have Karnofsky performance scale > 80% and ECOG status 0 or 1
- ATTR cardiac amyloidosis diagnosed within 5 years with specific diagnostic criteria excluding AL, heavy chain disease, multiple myeloma, or malignant lymphoproliferative disorders
- AL amyloidosis with cardiac involvement diagnosed within 5 years with histopathologic confirmation and signs of heart failure or cardiac involvement
- AL amyloidosis without cardiac involvement diagnosed within 5 years with histopathologic confirmation and absence of heart failure signs and cardiac involvement
You will not qualify if you...
- Unable to consent or complete all study procedures
- Unable to walk for 6 minutes or lie supine for 30 minutes
- Unable to hold breath for 10 seconds
- Contraindications to CMR such as uncontrolled claustrophobia or implanted devices
- Presence of implantable cardiac pacemaker or defibrillator
- History of complex congenital heart disease, intracardiac shunts (except patent foramen ovale), prosthetic valves, or arterial prosthesis
- Significant MRI artifact from prior studies
- Pregnant or breastfeeding women
- Weight 155 kg or greater
- Body dimensions exceeding 70 cm side-to-side or front-to-back
- Documented non-sinus rhythm within 1 week prior to screening
- For healthy controls, history of cardiomyopathy, structural heart disease, valvular disease more than mild, coronary artery disease, cardiac surgery, arrhythmias, abnormal myocardial thickness, kidney disease with low filtration rate, uncontrolled hypertension, multiple antihypertensive or diabetic medications, stroke or transient ischemic attack, smoking, plasma cell or malignant hematologic diseases, or BMI over 35 kg/m2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo imaging and exercise capacity tests including cardiac magnetic resonance imaging, transthoracic echocardiogram, and a six-minute walk test to assess cardiac structure and intracardiac flow.
1 visit (in-person)
Duration - Up to 5 years
Participants are observed following diagnostic assessments to monitor intracardiac flow biomarkers and cardiac amyloidosis progression.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
K
Kathy Brown
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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