Cardiac Amyloidosis Registry Study

Cedars-Sinai Medical Center5,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Amyloidosis, Immunoglobulin Light-chain

Interventions

RegistryOTHER

Observational, data collection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (23)

University of Arizona Sarver Heart Center

Outcomes

Primary Outcomes

Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis

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.

Time frame: 1997 - 2025

Quantify incidence of complications from cardiac amyloidosis

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 \[time frame 3 years\]

Time frame: 1997 - 2025

Data from ClinicalTrials.gov

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