(21683) Phase 2b open-label clinical study to evaluate the tolerability and safety of an initiation dose of 5 mg of Vericiguat in participants with chronic heart failure with reduced ejection fraction
This research study is looking at a new medicine called Vericiguat (also known as BAY 1021189) for individuals living with chronic heart failure that has reduced pumping ability. The main goal of this early-stage study (Phase 2b) is to see how well patients tolerate a 5mg starting dose of this medicine. This means we'll be checking if they can take the medicine for two weeks without stopping due to side effects, especially if their blood pressure drops too much. We'll also be carefully monitoring for any other side effects. This study is ‘open-label,’ meaning both the patients and doctors will know they are receiving the study drug. The aim is to gather important information about its safety and tolerability before it can be studied in larger groups.
At a glance
What is this study about?
This study is about a new medicine called Vericiguat (you might also see it called BAY 1021189) for people who have a long-term heart condition known as 'chronic heart failure with reduced ejection fraction'. This means your heart isn't pumping blood around your body as strongly as it should.
In this early stage of research, called a Phase 2b study, doctors are giving participants a specific starting dose of 5mg of Vericiguat. The main aim is to find out how well people can cope with this initial dose – this is called 'tolerability'. They want to see if patients can take this 5mg dose for two weeks without having to stop the medicine, especially if they experience moderate to severe low blood pressure, which can make you feel dizzy or faint. They'll also be carefully watching for any other side effects to make sure it's safe.
The information gathered from this study is really important. It helps researchers understand how the medicine works in people, what the right starting dose might be, and if it's safe enough to move on to larger and longer studies. These kinds of early studies are crucial steps in developing new treatments that could potentially help people with chronic heart failure.
Key takeaways
- This study tests a new 5mg dose of Vericiguat for chronic heart failure.
- It aims to see how well people tolerate this starting dose and if it's safe.
- Participants must have 'chronic heart failure with reduced ejection fraction'.
- Close monitoring for side effects, especially low blood pressure, is key.
- This is an early-stage study (Phase 2b) to gather important safety information.
- Both participants and doctors will know the study drug is being given ('open-label').
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.
However, it's not just about age and gender. You would need to have been diagnosed with 'chronic heart failure with reduced ejection fraction'. This means you have a long-term heart condition where your heart doesn't pump blood as effectively as it should.
There will also be other specific medical checks and criteria that the study doctors will need to review to make sure this study is safe and appropriate for you.
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 chronic heart failure where your heart's pumping ability is reduced?
- Are you able to commit to the study's visit schedule?
- Are you willing to take the study medication (Vericiguat) as prescribed?
- Are you comfortable with being closely monitored for side effects?
What does participation involve?
If you take part in this study, you will be given the study medicine, Vericiguat (BAY 1021189), at a starting dose of 5mg. The main part of the study involves taking this medicine and attending at least two visits, where the study team will monitor your health very closely.
During these visits, the study team will check your blood pressure and look for any side effects you might be experiencing. It’s particularly important they track whether you can continue taking the 5mg dose for the full two weeks without having to stop the medicine, especially due to symptoms like dizziness from low blood pressure. They will also record any other health changes you notice. The total duration of your participation in this specific monitoring period will be at least two weeks.
Potential risks and benefits
Locations (5)
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Common questions
What is 'chronic heart failure with reduced ejection fraction'?
It's a long-term condition where your heart doesn't pump blood around your body as strongly as it should.
What does 'tolerability' mean in this study?
It means how well you can take the starting 5mg dose of the medicine for two weeks without having to stop due to side effects, like very low blood pressure.
Is Vericiguat a new medicine?
Yes, it's a new medicine being tested. This study is an early stage (Phase 2b) to learn about its safety and how people react to it.
Will I know if I'm getting the actual study drug?
Yes, this is an 'open-label' study, which means both you and the doctors will know you are receiving the study medicine, Vericiguat.
How long will I need to take part?
The main part of the study to check your tolerability of the starting dose will involve at least a two-week period of taking the medicine and being monitored.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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