Cardiac Amyloidosis Registry Study

NCT ID: NCT05174338

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-08

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amyloidosis, Immunoglobulin Light-chain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AL and TTR amyloidosis

immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR)

Registry

Intervention Type OTHER

Observational, data collection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Registry

Observational, data collection

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jignesh Patel, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arizona Sarver Heart Center

Tucson, Arizona, United States

Site Status

UC San Diego Health, Sulpizio Cardiovascular Center

La Jolla, California, United States

Site Status

Scripps Health

La Jolla, California, United States

Site Status

University of California Davis

Sacramento, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

MedStar Health and Vascular Institute/Georgetown University School of Medicine

Washington D.C., District of Columbia, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Washington University in St. Louis

St Louis, Missouri, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Weill Cornell Medicine

New York, New York, United States

Site Status

The Mount Sinai Hospital

New York, New York, United States

Site Status

Columbia University Irving Medical Center, Clinical Cardiovascular Research Laboratory for the Elderly (CUMC/CCRLE)

New York, New York, United States

Site Status

Duke Health

Durham, North Carolina, United States

Site Status

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00000442

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Amyloidosis TTR Flow Reserve Evaluation
NCT05103943 ACTIVE_NOT_RECRUITING NA
Clinical Study for AL-CM
NCT04924998 RECRUITING
PL_GNT01_ISR_Grant 53234273
NCT06714019 ENROLLING_BY_INVITATION