ClinicalTrials.gg
Not yet recruitingNCT05793398Updated Mar 31, 2023

Biomaterial Collection - and Analysis in Cardiac Sarcoidosis

An observational study in Cardiac Sarcoidosis, sponsored by Heart Center Leipzig - University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-31.

Sponsored by Heart Center Leipzig - University Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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 disease's key molecular pathological mechanisms and identify new biomarkers for better diagnostics and individualized therapy.

02

Conditions studied

  • Cardiac Sarcoidosis

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03

In context

Sarcoidosis

271 studies on the registry are indexed under Sarcoidosis; 51 are open to participants now.

This study's planned enrollment of 100 is below the median of 130 across 109 observational studies indexed under Sarcoidosis.

Browse Sarcoidosis studies →

Lead sponsor

Heart Center Leipzig - University Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

tertiary care clinic patients with suspected inflammatory cardiomyopathy and/or conduction disorders and/or ventricular arrhythmias, suspected cardiac sarcoidosis.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

(a) 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 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients with psychiatric illness that impairs business or insight capacity.
  2. Patients with chronic heart failure due to coronary artery disease or valvular vitiation.
  3. severe underlying disease other than sarcoidosis that is likely to result in death within one year.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Endomyocardial biopsy-positive Cardiac sarcoidosis
  • Endomyocardial biopsy-negative non ischemic cardiomyopathy
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2023; primary completion for Apr 2028, 60 months later.

Of 59 non-industry observational studies under Sarcoidosis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 111. This study's planned 60 months is above that.

Counting every sponsor, half of 59 studies reached it within 49 months; a quarter within 20 and three quarters within 111.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2023
First posted
Mar 31, 2023
StartEst.
Apr 1, 2023
Primary completionEst.
Apr 1, 2028
CompletionEst.
Apr 1, 2029
Last update
Mar 31, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05793398
Lead sponsor
Heart Center Leipzig - University Hospital
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
First posted
Mar 31, 2023
Start date
Apr 1, 2023 (estimated)
Primary completion
Apr 1, 2028 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Mar 31, 2023

Study contacts

Hans Ebbinghaus, MD
Contact
Hans.Ebbinghaus@helios-gesundheit.de
0049341865252550
Borislav Dinov, MD
Contact
Borislav.Dinov@helios-gesundheit.de

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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