Cardiac SarcoidosisNCT05793398
Biomaterial Collection - and Analysis in Cardiac Sarcoidosis
An observational study of Cardiac Sarcoidosis, run by Heart Center Leipzig - University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sarcoidosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: tertiary care clinic patients with suspected inflammatory cardiomyopathy and/or conduction disorders and/or ventricular arrhythmias, suspected cardiac sarcoidosis.
Who may be able to join
- patients with a history of symptomatic cardiac sarcoidosis/inflammatory cardiomyopathy or b) patients with newly diagnosed heart failure with cardiac arrhythmias (ventricular tachycardia, conduction disturbances, etc.) that may indicate sarcoidosis or inflammatory cardiomyopathy or c) patients with image morphological suspicion of cardiac sarcoidosis or inflammatory cardiomyopathy (MRI, PET-CT) or (d) patients who require or have received a ventricular assist device (VAD) or cardiac transplantation due to suspected cardiac sarcoidosis or inflammatory cardiomyopathy and (e) written informed consent has been obtained from patients for study participation and consent for analysis of patient samples. Studies on pseudoanonymized samples will only be performed with appropriately signed informed consent.
Who cannot join
- Patients with psychiatric illness that impairs business or insight capacity.
- Patients with chronic heart failure due to coronary artery disease or valvular vitiation.
- severe underlying disease other than sarcoidosis that is likely to result in death within one year.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Borislav Dinov, MD contact
About this study
Official title: Pathomechanisms in Patients With Cardiac Sarcoidosis and Other Inflammatory and Familial Cardiomyopathies of Similar Phenotypic Appearance
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.
Read more
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 disease's key molecular pathological mechanisms and identify new biomarkers for better diagnostics and individualized therapy.
- Conditions
- Cardiac Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endomyocardial biopsy-positive Cardiac sarcoidosis | Not described | |
| Endomyocardial biopsy-negative non ischemic cardiomyopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD14++CD16+ - monocytes/macrophages in myocardial samples and peripheral blood correlates with disease activity
Sarcoidosis leads to a cellular TH1-mediated immune response with formation of non-necrotizing granulomas in affected organs, including the heart. Monocyte/macrophage subpopulations play an important role in the initiation of the TH1 immune response. Detection of specific immune cells such as CD14++CD16+ - monocytes/macrophages in myocardial samples and peripheral blood correlates with disease activity.
Measured: Baseline
Specific genetic variants, single nucleotide polymorphisms, and epigenetic markers are associated with an individually increased risk of disease.
Modern genetic testing methods can detect an individually increased risk of disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SarcoidosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig Medical Center, Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Erich and Hanna Klessmann Institute for Cardiovascular Research and Development, Max Delbrück Center for Molecular Medicine (MDC), Berlin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793398
- Sponsor's protocol ID
- CD1022
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathomechanisms in Patients With Cardiac Sarcoidosis and Other Inflammatory and Familial Cardiomyopathies of Similar Phenotypic Appearance
- ClinicalTrials.gov ID
- NCT05793398
- Acronym / sponsor ID
- CD1022
- Conditions
- Cardiac Sarcoidosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Collaborators
- University of Leipzig Medical Center, Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Erich and Hanna Klessmann Institute for Cardiovascular Research and Development, Max Delbrück Center for Molecular Medicine (MDC), Berlin
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 31 Mar 2023 (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.
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 disease's key molecular pathological mechanisms and identify new biomarkers for better diagnostics and individualized therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endomyocardial biopsy-positive Cardiac sarcoidosis | – | – |
| Endomyocardial biopsy-negative non ischemic cardiomyopathy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic patients with suspected inflammatory cardiomyopathy and/or conduction disorders and/or ventricular arrhythmias, suspected cardiac sarcoidosis.
Key inclusion criteria (1 listed)
- patients with a history of symptomatic cardiac sarcoidosis/inflammatory cardiomyopathy or b) patients with newly diagnosed heart failure with cardiac arrhythmias (ventricular tachycardia, conduction disturbances, etc.) that may indicate sarcoidosis or inflammatory cardiomyopathy or c) patients with image morphological suspicion of cardiac sarcoidosis or inflammatory cardiomyopathy (MRI, PET-CT) or (d) patients who require or have received a ventricular assist device (VAD) or cardiac transplantation due to suspected cardiac sarcoidosis or inflammatory cardiomyopathy and (e) written informed consent has been obtained from patients for study participation and consent for analysis of patient samples. Studies on pseudoanonymized samples will only be performed with appropriately signed informed consent.
Key exclusion criteria (3 listed)
- Patients with psychiatric illness that impairs business or insight capacity.
- Patients with chronic heart failure due to coronary artery disease or valvular vitiation.
- severe underlying disease other than sarcoidosis that is likely to result in death within one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CD14++CD16+ - monocytes/macrophages in myocardial samples and peripheral blood correlates with disease activity
Time frame: Baseline
Sarcoidosis leads to a cellular TH1-mediated immune response with formation of non-necrotizing granulomas in affected organs, including the heart. Monocyte/macrophage subpopulations play an important role in the initiation of the TH1 immune response. Detection of specific immune cells such as CD14++CD16+ - monocytes/macrophages in myocardial samples and peripheral blood correlates with disease activity.
Specific genetic variants, single nucleotide polymorphisms, and epigenetic markers are associated with an individually increased risk of disease.
Time frame: Baseline
Modern genetic testing methods can detect an individually increased risk of disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Borislav Dinov, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Sarcoidosis, run by Heart Center Leipzig - University Hospital.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Ebbinghaus, MD (0049341865252550, Hans.Ebbinghaus@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD14++CD16+ - monocytes/macrophages in myocardial samples and peripheral blood correlates with disease activity (time frame: Baseline). 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?
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 31 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.