An open-label, prospective, single centre study of the effects of Riociguat on RIght VEntricular size and function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
This research study is investigating a medicine called Riociguat for people who have specific types of high blood pressure in the lungs, known as Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH). The main aim is to carefully observe how Riociguat affects the right side of the heart, specifically its size and how well it pumps blood. Doctors will measure these changes over a period of 24 weeks. This is an 'open-label' study, meaning both the patients and the doctors know they are receiving Riociguat. It's also a 'Phase IV' study, which means the medicine is already approved but researchers are gathering more information about its long-term effects and how it works in real-world settings.
At a glance
What is this study about?
This study is focused on two specific health conditions: Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Both of these conditions involve high blood pressure in the arteries of the lungs, which can put a strain on the right side of your heart.
The researchers are studying a medicine called Riociguat. This medicine is already approved for use, but doctors want to learn more about its effects, especially on the right side of the heart. The main thing they will be looking at is whether Riociguat can change the size and how well the right side of the heart works over about six months. They believe that improving the function of the right side of the heart could be really beneficial for people with these lung conditions.
To understand these effects, doctors will use various tests, including heart scans, lung function tests, and a walking test. These tests will help them see if the medicine helps your heart pump more easily and if you can walk further or breathe better. The findings from this study will help doctors better understand how Riociguat works and who might benefit most from it.
Key takeaways
- Study focuses on Riociguat for pulmonary hypertension.
- Aims to understand effects on the heart's right side.
- Involves regular assessments over 24 weeks.
- Open to adults aged 18 and over, both men and women.
- It's a 'Phase IV' study, gathering more knowledge on an approved medicine.
Who may be eligible?
To be considered for this study, individuals must be at least 18 years old. There is no upper age limit, meaning older adults are also welcome to participate.
This study includes both men and women. The specific details about your health condition — whether you have Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension — would be discussed with the study doctors to ensure you meet the exact criteria for participation.
It's important to remember that the study doctors will review your full medical history to make sure the study is right for you and that Riociguat is a suitable treatment option for your specific case.
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 have Pulmonary Arterial Hypertension (PAH) or Chronic Thromboembolic Pulmonary Hypertension (CTEPH)?
- Are you able to attend study visits at the clinic?
- Are you comfortable with receiving Riociguat as the study medication?
What does participation involve?
If you decide to take part in this study, you will receive the medicine Riociguat. This is an 'open-label' study, which means both you and the doctors will know you are receiving this specific medication. You will have several study visits at a single medical centre over a period of 24 weeks (about 6 months).
During these visits, you will have several assessments to check your health and how the medicine is affecting you. These assessments will include heart scans (echocardiograms) to measure the size and function of your heart, particularly the right side. You will also have tests to check your lung function, such as spirometry, which measures how much air you can breathe in and out. A 6-minute walking test will also be conducted to see how far you can walk in that time.
Other tests may include blood tests, measurements of your blood pressure and heart rate, and possibly a cardiopulmonary exercise test, which involves exercising while doctors monitor your heart and lungs. There will be regular follow-up to monitor your progress and ensure your safety throughout the 24-week study period.
Potential risks and benefits
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Common questions
What is Pulmonary Hypertension?
It's a condition where the blood pressure in the arteries that go from your heart to your lungs is too high, making your heart work harder.
What is Riociguat?
It's a medicine used to treat certain types of pulmonary hypertension. This study is looking at how it specifically affects the heart's right side.
Will I get a placebo (dummy drug)?
No, this is an 'open-label' study, meaning all participants will receive Riociguat. Both you and your doctors will know you are getting the active medicine.
How long will I be in the study?
The study will last for 24 weeks, which is about six months.
What kind of tests will I have?
You'll have heart scans (echocardiograms), lung function tests, walking tests, and blood pressure checks, among others.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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