Clinical trial · Observational
Cardiac Amyloidosis Registry Study
Cardiac Amyloidosis Registry Study - A Multi-Center, Longitudinal, Observational Survey of Patients With Cardiac Amyloidosis
NCT05174338CI-TRIAL-00069353CARSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amyloidosis, Immunoglobulin Light-chain | Amyloidosis | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Registry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AL and TTR amyloidosis
- description
- immunoglobulin light chain amyloidosis (AL) and transthyretin amyloidosis (ATTR)
- interventionNames
- Other: Registry
Primary outcomes (2)
- measure
- Quantify disease severity at diagnosis, progression and survival in patients with cardiac amyloidosis
- timeFrame
- 1997 - 2025
- description
- 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.
- measure
- Quantify incidence of complications from cardiac amyloidosis
- timeFrame
- 1997 - 2025
- description
- 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 \[time frame 3 years\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDStern 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. PMID 37907148