A Phase IIb Randomised, Double-blind, Placebo-controlled, Multi-centre, Dose-ranging Study of AZD3427 in Participants with Heart Failure and Pulmonary Hypertension due to Left Heart Disease (WHO Group 2)
This study is looking at a new medicine called AZD3427 for people who have heart failure and high blood pressure in their lungs, which is caused by a problem with the left side of their heart. This is a common type of heart and lung condition. The main aim is to find out if AZD3427 can help improve how well blood flows through the lungs, and to see if different doses have different effects. We will also check if the medicine improves how people feel, their ability to exercise, and other measures of heart function. Some people will receive the new medicine, while others will get a dummy medicine (placebo) to compare the effects fairly.
At a glance
What is this study about?
This research study is focused on a health condition where the heart isn't pumping as well as it should (heart failure), and this also causes high blood pressure in the arteries of the lungs (pulmonary hypertension). This specific type of pulmonary hypertension happens because of issues with the left side of your heart. The combination of these problems can make everyday activities difficult and affect your quality of life.
The study aims to test a new investigational medicine, AZD3427, to see if it can help improve how the heart and lungs work together in people with this condition. We are particularly interested in seeing if it can reduce the pressure in the blood vessels in the lungs, making it easier for blood to flow through. We'll also be looking at whether the medicine improves symptoms, how far people can walk, and how their heart functions overall.
By carefully comparing the new medicine to a dummy treatment (placebo), we hope to understand if AZD3427 is effective and safe. Finding better ways to manage this complex condition could potentially lead to improved health and quality of life for many people.
Key takeaways
- Tests a new medicine (AZD3427) for heart and lung problems.
- Aims to improve blood flow and reduce pressure in lung arteries.
- Compares AZD3427 to a dummy treatment (placebo).
- Participation involves regular clinic visits and specific medical tests.
- Study duration is around 6 months.
- Your safety and consent are paramount.
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.
Because this study is very specific, you will also need to have been diagnosed with heart failure and high blood pressure in the lungs that is known to be caused by a problem with the left side of your heart. This is sometimes called WHO Group 2 pulmonary hypertension.
Detailed medical checks will be done by the study doctors to make sure you meet all the other specific health requirements for taking part. This is important to ensure the study is safe for you and that the results are reliable.
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.
- Am I aged 18 or over?
- Have I been diagnosed with heart failure?
- Do I have high blood pressure in my lungs (pulmonary hypertension)?
- Is my pulmonary hypertension known to be caused by a problem with the left side of my heart?
What does participation involve?
If you join this study, you'll be randomly assigned to receive either the new medicine, AZD3427, or a dummy medicine (placebo). Neither you nor your study doctor will know which you are receiving. Over a period of about 25 weeks (around 6 months), you'll have several visits to the clinic.
During these visits, doctors will perform special tests like right heart catheterisation (RHC) at the beginning and end of the study to measure pressures in your heart and lungs. You'll also have heart scans (echocardiograms) to check how your heart is working, and you’ll do a 6-minute walk test. We will also ask you to complete questionnaires about how you feel and take blood and urine samples to monitor your health and how the medicine is affecting your body. After the main 25-week period, there might be a short follow-up visit or contact.
Potential risks and benefits
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Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as well as it should, leading to symptoms like tiredness or breathlessness.
What is pulmonary hypertension?
Pulmonary hypertension is high blood pressure in the arteries of your lungs, which can make your heart work harder.
What does 'placebo' mean?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps us fairly compare if the new medicine works.
How long will the study last for me?
If you join, the main treatment part of the study will last about 25 weeks, which is roughly 6 months.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, and it won't affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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