Cardiac Amyloidosis Registry Study
- Conditions
- Amyloidosis, Immunoglobulin Light-chain
- Interventions
- Other: Registry
- Registration Number
- NCT05174338
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
This registry is a observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025.
- Detailed Description
Amyloidosis is a rare, multisystem disorder in which an insoluble protein is deposited in tissues, leading to organ dysfunction. Several proteins have been identified to potentially lead to amyloid cardiomyopathy (AC). Given the rare nature of these diseases, a large, multi-center effort to describe the characteristics of these patients and their outcomes with novel treatment modalities has not been established. (TBD) academic medical centers from the US and internationally will compile demographic, hemodynamic and organ-involvement data, as well as treatment strategies for AL and TTR amyloidosis.
This registry is an observational, multi-center study designed to collect data and analyze it retrospectively on patients with cardiac amyloidosis who have been evaluated and treated at major amyloid centers across the US and internationally between 1997 and 2025. It is expected that the total patient population will be approximately 5000 patients.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 5000
- Established diagnosis of AL or TTR cardiomyopathy identified or treated within the timeframe
- Specific to CSMC: If the individual provided consent while they were alive, and if sufficient information exists in their chart, their data will be included.
- Information on deceased individuals may be included, but only with the appropriate approval from the external site IRB and/or according to the federal regulations for the protection of human subjects.
- At Cedars-Sinai, records that specifically state not to be used in research will not be accessed. Patients who have enacted a No Research Flag or are noted as "Break the Glass" will not be included. For external sites, records that indicate No Research Flag or are noted as "Break the Glass" may be included based on institutional policies and appropriate approvals, as applicable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AL and TTR amyloidosis Registry immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR)
- Primary Outcome Measures
Name Time Method Quantify incidence of complications from cardiac amyloidosis 1997 - 2025 Determine incidence of arrhythmias (atrial fibrillation; ventricular arrhythmias) after diagnosis, renal dysfunction (rise in creatinine and development of end-stage renal disease), stroke, bleeding complications \[time frame 3 years\]
Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis 1997 - 2025 Clinical Outcomes: Disease severity at presentation, progression, and survival \[time frame 3 years\]. Severity and progression determined by change in NYHA Class, NT-ProBNP and troponin.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
NYU Langone Health
🇺🇸New York, New York, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
UC San Diego Health, Sulpizio Cardiovascular Center
🇺🇸La Jolla, California, United States
University of Arizona Sarver Heart Center
🇺🇸Tucson, Arizona, United States
Scripps Health
🇺🇸La Jolla, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of California Davis
🇺🇸Sacramento, California, United States
MedStar Health and Vascular Institute/Georgetown University School of Medicine
🇺🇸Washington, District of Columbia, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Duke Health
🇺🇸Durham, North Carolina, United States
Columbia University Irving Medical Center, Clinical Cardiovascular Research Laboratory for the Elderly (CUMC/CCRLE)
🇺🇸New York, New York, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Calgary
🇨🇦Calgary, Alberta, Canada