Amyloidosis, Immunoglobulin Light-chainCARSNCT05174338
Cardiac Amyloidosis Registry Study
An observational study of Amyloidosis, Immunoglobulin Light-chain, run by Cedars-Sinai Medical Center at 23 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyloidosis, Immunoglobulin Light-chain
- What is being tested?
- Registry
- How many people
- 5,000 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 8 Jan 2020to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Established diagnosis of AL or TTR cardiomyopathy identified or treated
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke Health
Durham, North Carolina, 27710
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
UC San Diego Health, Sulpizio Cardiovascular Center
La Jolla, California, 92037
Scripps Health
La Jolla, California, 92137
NYU Langone Health
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10021
The Mount Sinai Hospital
New York, New York, 10029
Columbia University Irving Medical Center, Clinical Cardiovascular Research Laboratory for the Elderly (CUMC/CCRLE)
New York, New York, 10032
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
University of California Davis
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84112
University of California, San Francisco
San Francisco, California, 94103
Washington University in St. Louis
St Louis, Missouri, 63110
University of Arizona Sarver Heart Center
Tucson, Arizona, 85724
MedStar Health and Vascular Institute/Georgetown University School of Medicine
Washington D.C., District of Columbia, 20010
About this study
Official title: Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
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.
Read the 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.
- Conditions
- Amyloidosis, Immunoglobulin Light-chain
- Being tested
- Registry
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
Observational, data collection
| Study group | Role | What they receive |
|---|---|---|
| AL and TTR amyloidosis | immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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]
Measured: 1997 - 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start8 Jan 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyloidosis, Immunoglobulin Light-chainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jignesh Patel, MD, PhD, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174338
- Sponsor's protocol ID
- STUDY00000442
- Acronym
- CARS
- Status last verified
- Sep 2023
- First submitted
- 13 Dec 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study design reflects IPD sharing between researchers based upon agrred set of data elements for study projects in the registry.
Publications
Stern LK, Grodin JL, Maurer MS, Ruberg FL, Patel AR, Khouri MG, Roth LR, Aras MA, Bhardwaj A, Bhattacharya P, Brailovsky Y, Drachman BM, Ebong IA, Fine NM, Gaggin H, Gopal D, Griffin J, Judge D, Kim P, Mitchell J, Mitter SS, Mohan RC, Ramos H, Reyentovich A, Sheikh FH, Sperry B, Carter S, Urey M, Vaishnav J, Vest AR, Kittleson MM, Patel JK. The Cardiac Amyloidosis Registry Study (CARS): Rationale, Design and Methodology. J Card Fail. 2024 May;30(5):669-678. doi: 10.1016/j.cardfail.2023.09.016. Epub 2023 Oct 30.
PubMed 37907148
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT05174338
- Acronym / sponsor ID
- CARS / STUDY00000442
- Conditions
- Amyloidosis, Immunoglobulin Light-chain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL and TTR amyloidosis | – | Other: Registryimmunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Established diagnosis of AL or TTR cardiomyopathy identified or treated
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegistryObservational, data collection | Other | AL and TTR amyloidosis |
Primary outcome
Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis
Time frame: 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.
Quantify incidence of complications from cardiac amyloidosis
Time frame: 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]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 37907148Stern LK, Grodin JL, Maurer MS, Ruberg FL, Patel AR, Khouri MG, Roth LR, Aras MA, Bhardwaj A, Bhattacharya P, Brailovsky Y, Drachman BM, Ebong IA, Fine NM, Gaggin H, Gopal D, Griffin J, Judge D, Kim P, Mitchell J, Mitter SS, Mohan RC, Ramos H, Reyentovich A, Sheikh FH, Sperry B, Carter S, Urey M, Vaishnav J, Vest AR, Kittleson MM, Patel JK. The Cardiac Amyloidosis Registry Study (CARS): Rationale, Design and Methodology. J Card Fail. 2024 May;30(5):669-678. doi: 10.1016/j.cardfail.2023.09.016. Epub 2023 Oct 30.
- Individual participant dataSharing planned: Yes. The study design reflects IPD sharing between researchers based upon agrred set of data elements for study projects in the registry.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis, Immunoglobulin Light-chain, run by Cedars-Sinai Medical Center at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis (time frame: 1997 - 2025). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.