Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793398
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-20
Brief Title:
Biomaterial Collection - and Analysis in Cardiac Sarcoidosis
Sponsor:
Heart Center Leipzig - University Hospital
Organization:
Heart Center Leipzig - University Hospital
Study Overview
Official Title:
Pathomechanisms in Patients With Cardiac Sarcoidosis and Other Inflammatory and Familial Cardiomyopathies of Similar Phenotypic Appearance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiac sarcoidosis CS is a complex disease that is characterized by the formation of inflammatory granulomas in the myocardium The exact underlying pathophysiology of the disease is not yet fully understood but it is believed to be related to dysregulation of the immune system Despite significant progress in recent years the disease remains difficult to diagnose and there is a high risk of severe complications such as life-threatening cardiac arrhythmias severe heart failure and sudden cardiac death in affected patients
Moreover the clinical presentation of CS can be similar to other inflammatory heart diseases or familial cardiomyopathies Thus it is challenging to differentiate between these diseases which can lead to a delayed diagnosis and poor prognosis It is unclear whether certain genetic variants play a role in the clinical course and prognosis of CS which highlights the need for more research in this area
The diagnosis of CS requires cardiac or extracardiac biopsy with granuloma detection which is an invasive and complex procedure Consequently the disease is thought to be underdiagnosed and many affected patients may not receive timely treatment resulting in excess mortality Early diagnosis and immunosuppressive treatment as well as defibrillator implantation if necessary are crucial in delaying disease progression preventing complications and improving prognosis
To better understand the key molecular pathological mechanisms underlying the development and maintenance of CS a prospective multicenter exploratory study has been initiated The project involves the collection storage and analysis of biological samples from blood myocardium and lymph nodes of patients with cardiac sarcoidosis or cardiomyopathies that present clinically and image morphologically similar The samples will be used for scientific investigations on disease mechanisms of cardiomyopathies as well as for identification of new biomarkers in cardiomyopathy diagnostics and for follow-up of therapeutic measures
The study will employ a range of classical biochemical methods such as ELISA RIA as well as more modern methods of molecular biology single cell sequencing single nucleus sequencing and systems biology genomics metabolomics or proteomics to identify key molecular pathological mechanisms in the development and maintenance of CS
In addition genetic analysis will be performed to investigate cardiomyopathy- and ion channel-associated genetic variants which is critical for improving diagnostics and early individualized therapy The study will be conducted on a multicenter basis with the Heart Center Leipzig serving as the initiator and lead center and the University Hospital Leipzig as the second study center Biochemical and molecular biological analyses will be performed on behalf of the study management at the Heart Center Leipzig the University Hospital Leipzig and the Erich and Hanna Klessmann Institute for Cardiovascular Research and Development of the Heart and Diabetes Center NRW and Max Delbrück Center for Molecular Medicine in Berlin
In conclusion CS is a complex and challenging disease that requires further research to better understand its underlying mechanisms and improve diagnostic and therapeutic strategies The prospective multicenter exploratory study will provide valuable insights into the diseases key molecular pathological mechanisms and identify new biomarkers for better diagnostics and individualized therapy
Moreover the clinical presentation of CS can be similar to other inflammatory heart diseases or familial cardiomyopathies Thus it is challenging to differentiate between these diseases which can lead to a delayed diagnosis and poor prognosis It is unclear whether certain genetic variants play a role in the clinical course and prognosis of CS which highlights the need for more research in this area
The diagnosis of CS requires cardiac or extracardiac biopsy with granuloma detection which is an invasive and complex procedure Consequently the disease is thought to be underdiagnosed and many affected patients may not receive timely treatment resulting in excess mortality Early diagnosis and immunosuppressive treatment as well as defibrillator implantation if necessary are crucial in delaying disease progression preventing complications and improving prognosis
To better understand the key molecular pathological mechanisms underlying the development and maintenance of CS a prospective multicenter exploratory study has been initiated The project involves the collection storage and analysis of biological samples from blood myocardium and lymph nodes of patients with cardiac sarcoidosis or cardiomyopathies that present clinically and image morphologically similar The samples will be used for scientific investigations on disease mechanisms of cardiomyopathies as well as for identification of new biomarkers in cardiomyopathy diagnostics and for follow-up of therapeutic measures
The study will employ a range of classical biochemical methods such as ELISA RIA as well as more modern methods of molecular biology single cell sequencing single nucleus sequencing and systems biology genomics metabolomics or proteomics to identify key molecular pathological mechanisms in the development and maintenance of CS
In addition genetic analysis will be performed to investigate cardiomyopathy- and ion channel-associated genetic variants which is critical for improving diagnostics and early individualized therapy The study will be conducted on a multicenter basis with the Heart Center Leipzig serving as the initiator and lead center and the University Hospital Leipzig as the second study center Biochemical and molecular biological analyses will be performed on behalf of the study management at the Heart Center Leipzig the University Hospital Leipzig and the Erich and Hanna Klessmann Institute for Cardiovascular Research and Development of the Heart and Diabetes Center NRW and Max Delbrück Center for Molecular Medicine in Berlin
In conclusion CS is a complex and challenging disease that requires further research to better understand its underlying mechanisms and improve diagnostic and therapeutic strategies The prospective multicenter exploratory study will provide valuable insights into the diseases key molecular pathological mechanisms and identify new biomarkers for better diagnostics and individualized therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None