Amyloidosis Clinical Trial
Official title:
DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)
This is a joint project by Heidelberg University and Greifswald University.
Our objective is to establish an unique national multi-center registry and biobank of well
phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical,
molecular and omics-based phenotyping to serve as:
1. central hub for clinical outcome studies.
2. joint resource for diagnostic and therapeutic trials.
3. common biomaterial bank.
4. resource for detailed molecular analyses on patients' biomaterials and patient specific
model systems.
The following basic research projects, called modules, will be tied to and rely on the
recruitment of CMP patients and the infrastructure provided by TORCH:
- Well phenotyped patients will be the starting point for comprehensive next-generation
genotyping, leading to advanced estimates of genotype-phenotype relationship and its
clinical impact.
- Functional analysis of novel genomic loci and their related molecular pathways will be
based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g.
zebrafish and mice) model systems.
- The integrated analysis of viral load and replication, inflammation, genotype and
clinical variables will define risk variables for inflammatory and hereditary CMP.
- By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic,
molecular biomarkers and histopathology for diagnosis and out-come prediction will be
defined on a national level.
The registry will also facilitate investigator initiated clinical trials.
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Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04893889 -
Substudy (NCT04456582): Noninvasive Assessment of Myocardial Stiffness by 2D-SWE Ultrasound Technique (Two-dimensional Shear Wave Elastography) in Patients With Amyloidosis and Fabry Disease.
|
N/A | |
Withdrawn |
NCT04943302 -
Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis
|
Phase 2 | |
Active, not recruiting |
NCT02909036 -
Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.
|
Phase 1 | |
Completed |
NCT02816476 -
Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis
|
Phase 2 | |
Completed |
NCT01083316 -
Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis
|
Phase 2 | |
Completed |
NCT01527032 -
Risk-adapted Therapy for Primary Systemic (AL) Amyloidosis
|
Phase 2 | |
Completed |
NCT02545907 -
A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis
|
Phase 1/Phase 2 | |
Recruiting |
NCT05263817 -
A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis
|
Early Phase 1 | |
Active, not recruiting |
NCT03201965 -
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
|
Phase 3 | |
Withdrawn |
NCT02589860 -
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
|
||
Recruiting |
NCT05635266 -
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
Completed |
NCT02574676 -
Quality of Life (QOL) Registry for Patients With AL Amyloidosis
|
||
Active, not recruiting |
NCT02260466 -
Prevalence and Post-surgical Outcomes of CARdiac Wild-type TransthyrEtin amyloidoSIs in Elderly Patients With Aortic steNosis Referred for Valvular Replacement.
|
N/A | |
Withdrawn |
NCT02462213 -
Prospective Identification of Cardiac Amyloidosis by Cardiac Magnetic Resonance Imaging
|
N/A | |
Recruiting |
NCT05577819 -
Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
|
N/A | |
Completed |
NCT01406314 -
SAP Depleter Dose Assessment Study in Patients
|
Phase 1 | |
Not yet recruiting |
NCT04985734 -
Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM) in Patients With Idiopathic Peripheral Neuropathy
|
N/A | |
Active, not recruiting |
NCT03584022 -
Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
|
N/A | |
Active, not recruiting |
NCT05235269 -
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
|
Phase 2 | |
Active, not recruiting |
NCT05199337 -
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
|
Phase 1/Phase 2 |