RecruitingOBSERVATIONAL

Diagnostic Criteria in Cardiac Sarcoidosis

This study is looking into how well current methods diagnose a rare heart condition called cardiac sarcoidosis. This condition can affect the heart in different ways, sometimes causing no symptoms and other times leading to serious problems. Doctors want to make sure they can spot the condition early and accurately, especially in people who could benefit from specific treatments. They're comparing various tests, including heart scans, blood tests, and heart tracings (ECG), to see which ones are most effective in identifying the condition. The goal is to improve how cardiac sarcoidosis is diagnosed, making it easier for doctors to give the right treatment to the right people at the right time.

At a glance

Status

Recruiting

Sponsor

Heart Center Leipzig - University Hospital

Enrolment target

100

Start

01 May 2023

Estimated completion

01 Jan 2027

Cardiac Sarcoidosis

What is this study about?

Cardiac sarcoidosis is a rare condition where tiny clumps of cells, called granulomas, form in the heart. These clumps can cause inflammation and scarring, which can make it harder for your heart to work properly. Sometimes, people don't even know they have it, while in other cases, it can lead to serious heart problems like an irregular heartbeat or heart failure.

Because the symptoms of cardiac sarcoidosis can be similar to other heart conditions, it can be quite tricky for doctors to diagnose it accurately. There are several different ways doctors currently try to diagnose it, using a mix of symptoms, special heart tests, imaging scans, and sometimes even a small tissue sample (biopsy).

This study is all about checking how good these current diagnostic methods truly are. Doctors want to see if the tests they use can reliably identify people with active inflammation in their heart. This is important because patients with active inflammation are the ones who are most likely to benefit from treatments designed to calm down the immune system, such as steroids. By making diagnoses more accurate, doctors hope to ensure that people get the right treatment sooner, potentially preventing more serious heart issues.

Key takeaways

This study evaluates current diagnostic methods for cardiac sarcoidosis.
It aims to improve early and accurate diagnosis for better effective treatment.
Participation involves various heart tests and scans, along with symptom evaluations.
Patients with confirmed or probable cardiac sarcoidosis will receive treatment.
The study includes long-term follow-up to monitor treatment effectiveness and progression.
Your involvement could help improve future care for others with this condition.

Who may be eligible?

This study is looking for people who doctors suspect might have cardiac sarcoidosis. This could be because you're under 65 and have suddenly developed a serious heart rhythm issue, like a specific type of irregular heartbeat, and doctors have ruled out other common causes like blocked arteries.

You might also be considered if you already have sarcoidosis affecting other parts of your body, and there's a suspicion it might be affecting your heart too. This could be suggested by symptoms like heart palpitations or unusual findings on your heart tests.

However, you won't be able to join if you're pregnant or breastfeeding, unwilling to follow the recommended treatment plan, or if you're under 18 years old. You also need to be able to understand and agree to take part in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you suspect you might have cardiac sarcoidosis, perhaps due to new heart rhythm problems or existing sarcoidosis elsewhere?
Have other common causes for your heart symptoms been ruled out?
Are you able and willing to follow the study's treatment and follow-up plan?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will carry out a thorough check-up. This will include discussing your symptoms, family health history, and any work-related risks. You'll have various tests such as an ECG (heart tracing), a chest X-ray, and blood tests to look for signs of sarcoidosis. You will also have advanced heart scans like a PET scan and a cardiac MRI, and potentially a biopsy where a tiny sample of heart tissue is taken.

Based on these results, you'll be placed into one of three groups: confirmed cardiac sarcoidosis, probable cardiac sarcoidosis, or unlikely cardiac sarcoidosis. If you're in the confirmed or probable groups, you'll receive treatment, likely with steroid medications. You'll then have follow-up visits after 3, 6, 12, and 24 months. These visits will involve checking your symptoms using special questionnaires, repeating some heart tests, and looking at your pacemaker (if you have one) to see how you're responding.

Potential risks and benefits

Taking part could help improve understanding of cardiac sarcoidosis, potentially leading to better diagnoses and treatments for others in the future. You will also receive careful monitoring and access to advanced diagnostic tests. Potential risks are generally associated with the tests themselves, such as slight discomfort from blood draws or the small risks linked with a biopsy or scans. You can withdraw from the study at any time without affecting your medical care.

Locations (1)

Heart Center of Leipzig
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is cardiac sarcoidosis?

It's a rare condition where small clumps of cells grow in the heart, causing inflammation and possibly affecting how your heart works.

Why is this study important?

It helps doctors find the best ways to accurately diagnose cardiac sarcoidosis, especially in people who would benefit most from treatment.

What kind of tests will I have?

You might have ECGs, blood tests, chest X-rays, special heart scans (PET and MRI), and potentially a small heart tissue sample (biopsy).

Will I receive treatment in this study?

If you're found to have definite or probable cardiac sarcoidosis, you will likely receive immune-suppressing medication, such as steroids.

How long will I be followed in the study?

You'll have follow-up appointments at 3, 6, 12, and 24 months after your initial check-up.

How to find out more

Borislav Dinov, MD

borislav.dinov@helios-gesundheit.de +49 341 865 1431 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.