TSPO Endothelial - EMPATHY
This research, called EMPATHY, is looking into Pulmonary Arterial Hypertension (PAH), a rare condition where blood vessels in the lungs become narrow, causing the heart to work much harder. We believe that specific cells lining these blood vessels, called 'endothelial cells,' and a protein on them, 'TSPO,' might be involved in this narrowing. The study uses a drug, XBD173, designed to target TSPO. Participants will take XBD173 for 6 weeks, followed by 4 weeks of observation. They will have heart and lung scans before and after treatment. The aim is to understand how XBD173 affects these cells and blood vessels, potentially leading to new ways to help people with PAH. Patients will be invited through their specialist hospital and need a special heart monitor already fitted for safety monitoring.
At a glance
What is this study about?
Pulmonary Arterial Hypertension (PAH) is a serious but rare heart and lung condition. In PAH, the blood vessels in your lungs become narrow and stiff. This means your heart has to work much harder just to pump blood through your lungs. Over time, this extra effort can strain your heart.
Researchers believe that tiny cells lining your blood vessels, called 'endothelial cells,' might play a key role in causing this narrowing. We've found a specific protein, called TSPO, on these cells that could be involved. This study, named EMPATHY, aims to explore if a new drug, XBD173, which targets this TSPO protein, can help us understand more about how these cells and blood vessels behave in PAH.
By understanding how XBD173 affects these cells, we hope to gain valuable insights into the causes of PAH. This knowledge could eventually lead to better ways to manage the condition and improve the lives of people living with PAH.
Key takeaways
- This study investigates a new drug (XBD173) for Pulmonary Arterial Hypertension (PAH).
- It aims to understand how XBD173 affects blood vessel cells in the lungs.
- Participation involves taking the drug for 6 weeks and follow-up for 4 weeks.
- You need to have an implanted heart monitor and stable PAH readings to join.
- Safety monitoring is done remotely with some optional hospital visits.
Who may be eligible?
This study is looking for people aged between 18 and 75 who have been diagnosed with certain types of Pulmonary Arterial Hypertension (PAH). This includes PAH that started without a known cause, runs in families, or is linked to other conditions like connective tissue disease.
You would need to have had a specific test (right heart catheterisation) that confirms your PAH meets certain measurements. Also, you must already have a special heart and lung monitor (a CardioMEMS™ system) implanted that helps doctors keep track of your condition, and your readings from this monitor should have been stable for at least a month.
There are also reasons why you might not be able to join. For example, if you are allergic to the study drug, have serious kidney or liver disease, low iron levels (anaemia), or certain blood conditions like sickle cell disease. Women who can get pregnant must use a very effective form of contraception (birth control) during the study, not including the contraceptive pill.
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 between 18 and 75 years old?
- Do you have a diagnosis of certain types of PAH?
- Do you already have an implanted CardioMEMS™ heart monitor?
- Have your readings from this monitor been stable for at least one month?
- Are you able to take study medication and attend assessments?
What does participation involve?
If you decide to take part, you'll be treated with the study drug, XBD173. You will take this drug for 6 weeks, splitting the daily dose into three smaller amounts (60mg each) throughout the day. After this treatment period, you'll be monitored for another 4 weeks without taking the drug.
Throughout the study, you'll have some assessments. This includes special scans of your heart and lungs, called an echocardiogram and an 18-FDG PET scan, both at the start and after you finish taking the medication. Your local hospital will invite you to participate. As you already have a special heart monitor, data from this device will be checked twice a week by a central clinical team to ensure your safety. Follow-up appointments can often be done remotely by phone or video call, with hospital visits being optional.
Potential risks and benefits
Locations (1)
- NIHR Imperial CRFVerified postcodeLondon, United Kingdom
Common questions
What is PAH?
PAH stands for Pulmonary Arterial Hypertension. It's a rare condition where blood vessels in the lungs become narrow, making it harder for the heart to pump blood, causing strain.
What is XBD173?
XBD173 is the drug being tested in this study. It's designed to target a specific protein (TSPO) on blood vessel cells, which researchers think might be involved in PAH.
How long does the study last?
You would take the study drug for 6 weeks, followed by 4 weeks of monitoring without the drug. So, the total active period for each patient is 10 weeks.
Do I have to go to the hospital a lot?
You'll have some hospital visits for scans before and after treatment. However, because you have a special monitor, ongoing safety checks and follow-up can often be done by phone or video call.
What are the main side effects of XBD173?
The most common reported side effects have included problems affecting the nervous system (like dizziness) and digestive system (like an upset stomach). These were not more common than with a dummy pill in other studies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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