ARETHA: cARdiomems vEriciguaT Heart fAilure (A double-blind randomized placebo-controlled trial of vericiguat in heart failure patients with CardioMEMS™ HF System)
The ARETHA study is for people living with a type of heart failure where their heart doesn't pump blood as strongly as it should. This condition is sometimes called HFrEF. The study is investigating a medication named Verquvo to see if it can help improve heart health. Specifically, it aims to find out if Verquvo can lower the pressure in the blood vessels of the lungs, compared to taking a dummy pill that contains no medicine (a placebo). This research is for people who already have a small heart monitoring device called CardioMEMS implanted. The study will also check if Verquvo can reduce another important marker in the blood related to heart failure, called NT-proBNP.
At a glance
What is this study about?
Heart failure means your heart isn't pumping blood around your body as well as it should. This can lead to symptoms like breathlessness and tiredness. In some cases, pressure can build up in the blood vessels of your lungs, making the heart work even harder. The ARETHA study is exploring whether a medication called Verquvo could help by lowering this pressure in the lungs.
This study focuses on a specific type of heart failure where the heart's main pumping chamber doesn't squeeze as strongly as it should. Participants in this study will already have a small device called CardioMEMS implanted. This device helps doctors monitor pressure changes in the lungs, which can be an early sign of worsening heart failure.
The main goal of the study is to compare Verquvo with a placebo (a tablet that looks like the study drug but contains no active medicine). Half of the participants will receive Verquvo, and the other half will receive the placebo. Doctors will monitor the pressure in your lungs using your CardioMEMS device and also check blood tests to see if Verquvo makes a difference.
Key takeaways
- The ARETHA study is testing a medicine called Verquvo for heart failure.
- It aims to see if Verquvo can lower lung pressure in heart failure patients with a CardioMEMS device.
- This is a Phase IV study, meaning it's looking at an approved drug in a new way.
- Participants will receive either Verquvo or a dummy pill (placebo).
- All adults (18+) with a specific type of heart failure and a CardioMEMS device may be eligible.
- The study helps us learn more about managing heart failure.
Who may be eligible?
To join the ARETHA study, you need to be an adult, aged 18 or older, and can be male or female. You must have a diagnosis of heart failure where your heart's main pumping chamber doesn't squeeze as strongly as it should (this is sometimes called HFrEF).
Additionally, you need to have a special heart monitoring device called a CardioMEMS HF System already implanted. Your doctor will be able to confirm if you meet these main requirements.
There will also be other health checks and tests your doctor will perform to make sure the study is a safe and suitable option for you. These might include checking your overall health and any other medications you are taking.
- Are you 18 years old or older?
- Do you have a diagnosis of heart failure where your heart doesn't pump strongly (HFrEF)?
- Do you currently have a CardioMEMS HF System device implanted?
- Are you able to attend regular clinic visits and follow study instructions?
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 the ARETHA study, you would receive either the study medication (Verquvo in different doses) or a dummy pill (placebo). You wouldn't know which you are receiving, and neither would your study doctor, which is called a 'double-blind' study. You would take the tablets as instructed by the study team.
Taking part would involve regular visits to the clinic for check-ups, blood tests, and to review your health. Your CardioMEMS device readings would also be monitored. The study will last for a certain period, and the medical team will explain the full schedule of visits and procedures. All study treatments and assessments would be provided at no cost, and you would be free to withdraw from the study at any time.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood around your body as efficiently as it should. It can lead to symptoms like shortness of breath and feeling very tired.
What is CardioMEMS?
CardioMEMS is a small device that is implanted in your body to monitor pressures in your lungs, helping your doctors keep track of your heart failure.
What is a placebo?
A placebo is a 'dummy' tablet that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual drug.
Will I know if I'm getting the real medicine or the placebo?
No, in this 'double-blind' study, neither you nor your study doctor will know if you are receiving Verquvo or the placebo. This helps ensure fair results.
What is Verquvo?
Verquvo is the name of the medication being tested in this study. It comes as film-coated tablets in different strengths: 2.5 mg, 5 mg, and 10 mg.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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