A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)
The KATALYST-AV study is looking into a new medication, ataciguat, for adults with moderate calcific aortic valve stenosis. This is a condition where the main valve leaving the heart becomes stiff and narrow due to calcium build-up, making it harder for blood to flow. The study aims to find out if ataciguat can slow down how quickly this condition gets worse. Participants will receive either the study drug or a dummy pill (placebo) and be closely monitored. Doctors will check their heart function and how well they can exercise over 48 weeks using tests like echocardiograms and exercise tests. The main goal is to see if ataciguat can help keep the valve opening wider and improve people's ability to be active.
At a glance
What is this study about?
This study, called KATALYST-AV, is investigating a new medication called ataciguat for a heart condition known as moderate calcific aortic valve stenosis. In this condition, the aortic valve, which is like a one-way door letting blood out of your heart to the rest of your body, becomes stiff and narrowed. This narrowing is due to a build-up of calcium, making it harder for your heart to pump blood effectively. Over time, this condition can worsen, and you might experience symptoms like breathlessness or chest pain.
The purpose of this research is to see if ataciguat can help slow down the progression of this valve problem. Currently, there isn't a specific medication that can stop or reverse this narrowing, so doctors usually wait until the condition becomes severe enough to require surgery to replace the valve. This study hopes to find out if taking ataciguat could delay or even prevent the need for such surgery by keeping the valve functioning better for longer.
Participants in the study will be given either the new medicine or a 'placebo', which looks exactly like the study medicine but contains no active drug. This is done to fairly compare the effects of the new drug against not taking it. Throughout the study, medical staff will use various tests, such as heart scans (echocardiograms) and exercise tests, to check how your heart valve is working and how your overall fitness changes. They want to measure if the valve opening stays wider and if your ability to exercise improves or doesn't get worse.
Key takeaways
- Tests a new medicine, ataciguat, for moderate aortic valve stenosis.
- Aims to slow down the stiffening and narrowing of the heart valve.
- Compares the new drug against a dummy pill (placebo).
- Involves regular check-ups, heart scans, and exercise tests for 48 weeks.
- Open to adults aged 18 and over with the condition.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older. Both men and women are welcome to take part.
You would be considered for this study if you have been diagnosed with moderate calcific aortic valve stenosis. This specifically refers to how much the main valve leaving your heart has become stiff and narrowed due to calcium build-up.
However, there are also some reasons why you might not be able to join. These can include other serious medical conditions you might have, or other medications you are currently taking. Doctors will review your full medical history to make sure the 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?
- Have you been diagnosed with moderate calcific aortic valve stenosis?
- Are you able to attend regular clinic visits for about a year?
- Are you willing to take the study medication daily (either the drug or placebo)?
- Are you comfortable with undergoing heart scans and exercise tests?
What does participation involve?
If you decide to take part in this study, you would be assigned to either receive the study drug, ataciguat, or a dummy pill (placebo). You will visit the clinic regularly for check-ups and medical assessments over a total period of 48 weeks (just under a year). These visits will involve various tests to monitor your heart health and overall well-being. These tests may include heart scans (echocardiograms), which use sound waves to create images of your heart, and exercise tests to see how your heart responds during physical activity. You might also have blood tests and other routine checks. Throughout this time, you will take the assigned medication daily. All assessments will be clearly explained to you.
Potential risks and benefits
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Common questions
What is calcific aortic valve stenosis?
It's a condition where the main valve leaving your heart stiffens and narrows due to calcium build-up, making it harder for blood to flow out.
What is 'ataciguat'?
Ataciguat is the name of the new experimental medicine being tested in this study to see if it can help slow down valve stiffening.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps researchers fairly compare its effects.
How long will the study last if I take part?
The study involves regular visits and medication for about 48 weeks, which is just under a year.
Will I know if I'm taking the real drug or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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