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Cardiac SarcoidosisNCT05793398

Biomaterial Collection - and Analysis in Cardiac Sarcoidosis

An observational study of Cardiac Sarcoidosis, run by Heart Center Leipzig - University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05793398
Study groupRoleWhat they receive
Endomyocardial biopsy-positive Cardiac sarcoidosisNot described
Endomyocardial biopsy-negative non ischemic cardiomyopathyNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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.

  1. First posted31 Mar 2023
  2. Study start1 Apr 2023 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

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
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

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.

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