RecruitingInterventional

Pace and diagnose in suspected cardiomyopathy

This study is for adult patients who are having a pacemaker (or similar cardiac device) fitted and are also suspected of having specific heart conditions called cardiac sarcoidosis or cardiac amyloidosis. Researchers want to see if a newer method of taking small heart tissue samples (biopsies) is safe and effective compared to the standard method. By analysing these samples, they hope to identify the underlying cause of a patient's heart disease. Finding the cause allows for specific treatments that can slow down the disease and prevent serious complications. The study involves taking heart tissue samples during your planned procedure and analysing them at Royal Papworth Hospital.

At a glance

Status

Recruiting

Sponsor

University Hospitals Sussex NHS Foundation Trust

Enrolment target

Start

10 Dec 2025

Estimated completion

01 Jul 2027

Patients with suspected cardiac sarcoidosis and or cardiac amyloidosis

What is this study about?

This study is trying to find better ways to understand and diagnose certain heart conditions. Sometimes, when people have problems with their heart rhythm or their heart's ability to pump blood well, the cause isn't immediately clear. Two conditions called cardiac sarcoidosis and cardiac amyloidosis can lead to these issues. If doctors can identify these conditions, there are specific treatments that can help prevent the disease from getting worse and reduce the risk of serious health problems.

To find out if someone has these conditions, doctors sometimes need to take a very small sample of heart tissue, called a biopsy. This study focuses on patients who are already having a special heart device implanted, like a pacemaker. During this procedure, doctors can take these tissue samples. The study will compare the usual way of taking these samples (using tiny forceps) with a newer method that uses a special pacing wire to collect the sample. Both types of samples will then be examined to look for signs of these heart conditions.

The main goal is to see how well these different methods work and if the newer method is just as safe and effective. By getting clear diagnoses, doctors can offer the best possible care. The information from this study could help improve how these heart conditions are diagnosed and treated for many patients in the future.

Key takeaways

This study helps diagnose specific heart conditions during your pacemaker procedure.
It aims to find the cause of heart problems, not just treat symptoms.
You won't have extra operations; samples are taken during your planned procedure.
Potential benefit: A precise diagnosis can lead to better, targeted treatments.
You will be closely monitored for any risks, and precautions are taken.
You can decide not to participate or withdraw at any time.

Who may be eligible?

You might be able to take part in this study if you are an adult aged 18 or over. This study is specifically for people who are already scheduled to have a cardiac device (like a pacemaker) implanted. Along with needing this procedure, doctors must also suspect that you might have either cardiac sarcoidosis or cardiac amyloidosis, based on your symptoms or earlier tests.

However, there are some reasons why you wouldn't be able to join. You can't take part if you are under 18, or if you are pregnant or breastfeeding. Also, if you're already involved in another medical study that involves new treatments or procedures, you wouldn't be able to participate in this one. It's really important that you are able to understand what the study involves and can give your permission to take part.

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?
Are you already scheduled to have a pacemaker or similar heart device implanted?
Do your doctors suspect you might have cardiac sarcoidosis or cardiac amyloidosis?
Are you able to understand what's involved and give your permission to take part?
Are you NOT pregnant or breastfeeding?
Are you NOT currently part of another clinical trial involving a treatment or procedure?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would happen when you are already having your cardiac device implanted. During this procedure, the doctors will take small samples of your heart tissue using two different methods. One method is the standard way, and the other is a new method being looked at in this study. Both types of samples will be sent to a special lab at Royal Papworth Hospital for analysis.

After your procedure, you'll be monitored closely in the hospital, as is standard practice. The study aims to recruit patients over 18 months, and your involvement regarding the biopsy samples occurs during your single planned procedure. You will then have follow-up appointments as is standard for your condition, typically for 4-6 months, and these will not be extra visits specifically for the study. The total duration for which patients are involved in the study's data collection for their condition is expected to align with your normal follow-up schedule.

Potential risks and benefits

A potential benefit of joining this study is that it might help pinpoint the exact cause of your heart condition. Instead of just treating your symptoms, finding a specific diagnosis like cardiac sarcoidosis or amyloidosis means you could receive specialised treatments that can slow down the disease and prevent serious problems. However, there are some potential risks. You will be exposed to a small amount of X-ray radiation, but strict guidelines are followed to keep this as low as possible. There's also a small chance of temporary slow heart rhythms, but since you're already having a pacemaker procedure, doctors can immediately provide support if needed. Another rare risk is bleeding around the heart; however, doctors will be very careful by guiding the biopsy tools to the safest areas, and you'll be closely monitored for any signs of this, with treatments readily available if it occurs. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Sussex NHS Foundation Trust
City only
Worthing, England

Common questions

What is cardiac sarcoidosis or amyloidosis?

These are conditions where unusual proteins or inflammatory cells build up in your heart, which can affect how it works and lead to problems like abnormal heart rhythms or heart failure.

Will I have extra procedures if I join?

No, your biopsy samples will be taken during your already planned procedure to implant your cardiac device, so there are no additional operations involved.

What happens to the heart samples?

The tiny heart samples will be sent to Royal Papworth Hospital for special tests to help identify the cause of your heart disease.

How long will the study last for me?

Your direct participation in the study involves the biopsy during your cardiac device procedure. Afterward, you will follow your usual medical follow-up plan for about 4-6 months.

Who is paying for this study?

The study is being funded by an internal research program at University Hospitals Sussex NHS Foundation Trust in the UK.

How to find out more

Rebecca Godfrey

rebecca.godfrey@nhs.net +44 (0)1273696955 Official trial record

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