Pulmonary REsistance modification under treatment with Sacubitil/valsartaN in paTients with HeartFailure with reduced ejection fraction
This study, for people with a type of heart failure where the heart struggles to pump blood effectively, is investigating how a medicine called Entresto (which is already used for heart failure) affects the blood vessels in the lungs. Researchers want to see if Entresto can improve blood flow and reduce pressure in the lungs. They will also compare it to another heart medication called Enalapril and a dummy treatment (placebo). The main goal is to measure changes in lung blood pressure and how much resistance there is to blood flow in the lungs. This is a Phase IV trial, meaning the drug is already approved and the study is looking at new ways it might help patients.
At a glance
What is this study about?
You're reading about a medical study for people living with a type of heart failure called 'heart failure with reduced ejection fraction'. This means your heart muscle doesn't pump blood around your body as strongly as it should. In this study, doctors want to find out more about how a medicine called Entresto affects the blood vessels in your lungs. Sometimes, with heart failure, the blood pressure in the lungs can go up, and it can become harder for blood to flow through them. Entresto is already an approved medicine for heart failure, and this study aims to see if it can help improve these lung-related issues.
The main things the researchers will be carefully measuring are changes in the pressure inside the arteries of your lungs and how much resistance there is to blood flowing through them. They will compare Entresto with another common heart medicine called Enalapril, and also with a 'placebo' which looks like the real medicine but contains no active drug. This helps them understand whether the changes they see are truly due to the active medication.
This study is also looking at many other important aspects of health, like how far you can walk in six minutes, how well your heart and lungs work during exercise, and how your heart looks on ultrasound scans. They'll also be tracking important health events like hospital stays and, very importantly, how your quality of life changes over time. By looking at all these different things, they hope to get a full picture of how Entresto might help people with heart failure.
Key takeaways
- This study explores how Entresto affects blood pressure and flow in the lungs for people with heart failure.
- It compares Entresto with Enalapril and a placebo.
- The study lasts about one year and involves various medical checks and tests.
- Participants will take either Entresto, Enalapril, or a dummy pill.
- The study aims to understand benefits to lung health and overall quality of life.
Who may be eligible?
This study is open to both men and women aged 18 years and older. There's no upper age limit, meaning older adults are very welcome to take part if they meet other health requirements.
To be considered for this study, you must have been diagnosed with heart failure where your heart's main pumping chamber (the left ventricle) is not pumping blood as strongly as it should. Your doctor will be able to tell you if this description matches your condition.
There will be other specific health checks and tests that the study doctors will go through with you to make sure the study is right and safe for you. It's always a good idea to discuss this with your own doctor if you are interested.
- Are you 18 years old or older?
- Have you been diagnosed with heart failure where your heart doesn't pump strongly?
- Are you able to attend regular study visits for about a year?
- Are you willing to take study medication as directed?
- Are you willing to undergo various heart and lung 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 in this study, you would first have a screening visit to see if you are a good fit. If so, you would be given one of the study medicines: Entresto, Enalapril, or a placebo (a dummy pill). You would take this medication regularly as instructed by the study team. You would attend several scheduled visits over a period of up to 52 weeks (about a year). These visits would involve various tests including blood pressure checks, blood tests, heart ultrasound scans (echocardiograms), and exercise tests like a 6-minute walk test or a more detailed exercise test using a mask to measure your breathing (cardiopulmonary exercise test). You would also fill out questionnaires about your quality of life and how you're feeling. There will be regular follow-up to monitor your health and any side effects you might experience. The total duration of your participation, from start to finish, would be around one year.
Potential risks and benefits
Locations (1)
- —Poland
Common questions
What is 'heart failure with reduced ejection fraction'?
This means your heart muscle isn't pumping blood as strongly as it should, making it harder for blood to circulate around your body properly.
What is Entresto?
Entresto is a medication already approved and commonly used to treat heart failure. This study is exploring if it has additional benefits for blood flow in the lungs.
What is a placebo?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare how effective the actual medicine is.
What kind of tests will I have?
You might have blood pressure checks, blood tests, heart ultrasound scans, and exercise tests to see how your heart and lungs are working.
How long does the study last?
Your involvement in the study, including all visits and follow-ups, would last for about one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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