Clinical trial NCT05174338: Cardiac Amyloidosis Registry Study
Official title: Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Amyloidosis, Immunoglobulin Light-chain
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Established diagnosis of AL or TTR cardiomyopathy identified or treated

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis
timeFrame: 1997 - 2025
measure: Quantify incidence of complications from cardiac amyloidosis
timeFrame: 1997 - 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Sarver Heart Center
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Health, Sulpizio Cardiovascular Center
state: California
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Washington
country: United States
facility: MedStar Health and Vascular Institute/Georgetown University School of Medicine
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center, Clinical Cardiovascular Research Laboratory for the Elderly (CUMC/CCRLE)
state: New York
city: Durham
country: United States
facility: Duke Health
state: North Carolina
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References: