Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Ivy Wanjiku
+44 20 7317 7544
ivy.wanjiku@nhs.net


Dr Benjamin Schreiber
+44 20 7317 7544
benjamin.schreiber@nhs.net


Study Location:

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Be Part of Research - Trial Details - Scleroderma heart study

Scleroderma heart study

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Systemic sclerosis with heart involvement


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Scleroderma is a rare disease affecting a few thousand patients in the UK. The cause is not known. Patients develop fibrosis (a kind of scar tissue) in the skin, making it tight and hard. Internal organs are often affected too, including the lungs, kidney and bowel. Scleroderma can affect the heart, which can be mild or severe and devastating. Because this complication is uncommon, little is known about how best to diagnose and treat this condition. Current practice is to use MRI scans and sometimes to take samples (biopsies) of the heart to make a diagnosis of scleroderma heart involvement. Treatment is often with drugs to suppress the immune system. However, it is not known how much inflammation (swelling) there is in the heart in patients with scleroderma or whether the treatment might work to suppress that inflammation. In this study, a type of scan called a PET-CT scan will be performed on patients who we suspect have heart involvement from their scleroderma. This scan is already widely used in patients with cancer and in some other conditions. It involves the injection into a regular vein of sugar with a tracer attached to it, so the scan can track where the sugar is taken up. The aim of this study is to find out if a PET-CT scan is an effective assessment to use in patients thought to have heart involvement from scleroderma.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Aug 2016 01 Jul 2020

All patients are recruited at the Scleroderma centre and National Pulmonary Hypertension Service at the Royal Free Hospital. After signing an informed consent form, participants undergo a heart assessment to check that they are suitable to take part. Following this, health information is taken and patients undergo a PET-CT scan and a pregnancy test (if female of child bearing potential). A follow up visit, involving similar assessments is carried out 6-9 months after screening if required.


Adults who have scleroderma with suspected heart involvement.

You can take part if:



You may not be able to take part if:


1. Inability to lie flat2. Pregnancy or breastfeeding3. Unwilling to undergo pregnancy test prior to study (in women of child bearing potential)4. Coronary artery disease. This needs to be excluded by CT coronary angiogram, myocardial perfusion scanning, dobutamine stress echocardiogram or conventional coronary angiogram5. Inclusion in a clinical trial involving an investigational medical product in the last 28 days


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Free Hospital
    Clinical Trials Rheumatology Department Lower Ground Floor
    London
    NW3 2QG

There are no direct benefits involved with participating. The main risk involved in this study will be the radiation dose received by patients. All patients included in this study will undergo a single 18FDG PET-CT scan. Patients with a positive scan may be offered one further scan after a course of treatment. The study protocol has been written in consultation with medical physics expert at the Royal Free who has reviewed and approved radiation doses. Additionally in order to avoid harm to unborn children, patients of child bearing potential will have a pregnancy test at every trial visit. If the test is positive patients will be withdrawn from the study immediately.


The study is sponsored by Royal Free London NHSFoundation Trust and funded by Royal Free Charity.




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Read full details for Trial ID: ISRCTN55643149
Last updated 31 January 2022

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.