IMPACT-CTEPH Initial dual oral coMbination therapy versus standard-of-care initial oral monotherapy Prior to balloon pulmonary Angioplasty in patients with inoperable Chronic thromboembolic pulmonary hyperTension”
This study is for people with a serious lung condition called Chronic Thromboembolic Pulmonary Hypertension (CTEPH). This condition happens when old blood clots block blood vessels in the lungs, making it hard for blood to flow through. The study aims to find out if using two medicines at the same time is more effective than using just one for patients who can't have surgery. This treatment would be given before a procedure called balloon pulmonary angioplasty, which helps open up the blocked blood vessels. By comparing these approaches, researchers hope to improve how well people with CTEPH breathe and feel.
At a glance
What is this study about?
This study is investigating a serious long-term lung condition called Chronic Thromboembolic Pulmonary Hypertension (CTEPH). In CTEPH, old blood clots stop blood from flowing properly through the arteries in your lungs. This makes your heart work much harder to pump blood, leading to symptoms like breathlessness, tiredness, and chest pain. For some people, surgery can remove these clots, but for others, surgery isn't an option. This study is focusing on these patients.
The main goal of the study is to see if starting treatment with two specific oral medications (taken by mouth) works better than starting with just one for patients who cannot have surgery. This treatment would be given *before* a procedure called balloon pulmonary angioplasty (BPA), which involves using a small balloon to open up the blocked blood vessels in your lungs. Researchers want to understand if this combined approach helps improve the measurements of blood pressure in your lungs more effectively than the current standard treatment, where only one medication is given initially.
Ultimately, the results of this study could help doctors decide the best way to treat people with inoperable CTEPH. By finding more effective treatments, the aim is to help patients feel better, improve their ability to be active, and enhance their overall quality of life.
Key takeaways
- Tests new drug combinations for a serious lung condition (CTEPH).
- Focuses on patients who cannot have surgery.
- Compares one medicine versus two before a lung procedure.
- Aims to improve breathing and overall well-being.
- Involves regular health checks and assessments.
- Participation is voluntary and you can leave at any time.
Who may be eligible?
To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
The main condition for joining is that you have a specific lung problem called inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Your doctor will confirm this, meaning that surgery to remove blood clots from your lungs isn't possible for you.
There will also be other specific medical checks and tests to make sure the study treatment is safe and suitable for you. Your study doctor and nurse will go through all of these details with you.
- Are you 18 years old or older?
- Have you been diagnosed with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)?
- Has your doctor told you that surgery for your CTEPH is not an option?
- Are you willing and able to attend regular hospital visits for check-ups and tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be randomly assigned to receive either one medicine (the standard care) or two medicines together. This decision is made by chance, like flipping a coin, to ensure fairness in the study. You will take these medicines by mouth.
Throughout the study, you'll have regular hospital visits. During these visits, doctors and nurses will carry out various checks and tests. These might include blood tests, measurements of your breathing and lung pressure, walking tests (like seeing how far you can walk in 6 minutes), and questionnaires about how you're feeling and your quality of life. These assessments will help the study team understand how well the treatment is working and if there are any side effects.
Some participants may also have a procedure called balloon pulmonary angioplasty (BPA) as part of their ongoing care. The total duration of your participation in the study, including follow-up, will be clearly explained to you by the study team.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is CTEPH?
CTEPH is a long-term lung condition where old blood clots stop blood from flowing through the lung arteries, making your heart work harder.
What does a 'clinical trial' mean?
A clinical trial is a research study that looks at new ways to prevent, detect, or treat diseases. This helps us find better treatments for patients.
What is 'inoperable' CTEPH?
This means that surgery to remove the blood clots from your lungs is not a suitable option for your particular situation.
Will I know if I'm getting one or two medicines?
You will be randomly assigned to a group, like drawing lots, and you might not know which specific treatment you are receiving until the study is over. This helps ensure fair results.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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