A Phase 3, Multi-center, Randomized, Double-blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
This study is investigating a new medication called Aficamten for adults living with a heart condition known as symptomatic obstructive hypertrophic cardiomyopathy. This condition makes the heart muscle thicken, making it harder for blood to flow. The trial aims to find out if Aficamten works better than Metoprolol, a widely used heart medication, in improving symptoms and heart function. Participants will be randomly given either Aficamten or Metoprolol, with some receiving a dummy pill (placebo) to ensure fair comparison. Researchers will carefully check changes in how much oxygen the body uses during exercise, how people feel, and specific measurements of heart health. The main goal is to see if Aficamten can help people with this condition live more comfortably and with better heart health.
At a glance
What is this study about?
This study is for adults who have a heart condition called symptomatic obstructive hypertrophic cardiomyopathy. This just means that the main pumping chamber of their heart (the left ventricle) has become too thick, making it harder for blood to leave the heart and get to the rest of the body. This can cause symptoms like breathlessness, chest pain, or feeling tired.
The study aims to see if a new medicine, Aficamten, can help improve how well people with this condition feel and how efficiently their heart works. It's being compared against Metoprolol, which is a common medicine already used to treat heart problems. Researchers want to make sure any new treatment is both effective and safe for patients.
To do this, some people will receive Aficamten, others will get Metoprolol, and a few might get a 'dummy' pill (placebo) for extra comparison. Doctors will then carefully measure changes in how much oxygen your body uses during exercise, how your symptoms improve, and other signs of heart health over 24 weeks. This careful approach helps them understand if Aficamten is a good new option for people with this condition.
Key takeaways
- Tests a new heart medicine (Aficamten) against a standard one (Metoprolol).
- For adults with a specific heart thickening condition.
- Aims to improve symptoms and heart function.
- Volunteers will receive one of the medicines or a dummy pill.
- Involves regular clinic visits and health checks over 24 weeks.
- Helps researchers understand the new medicine's safety and effectiveness.
Who may be eligible?
This study is looking for adult volunteers, aged 18 years or older, who have been diagnosed with symptomatic obstructive hypertrophic cardiomyopathy. Both men and women are welcome to take part.
Before joining, doctors will check to make sure the study is a good fit for you. This will involve looking at your health history and doing some tests. They want to ensure your particular heart condition and overall health match what the study needs.
Because this is a specific heart condition, there will be certain medical requirements you need to meet. The study team will explain all the details to you during the screening process to make sure you understand if you can join.
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 symptomatic obstructive hypertrophic cardiomyopathy?
- Are you able to attend regular clinic visits and tests?
- Are you willing to potentially receive either the new medicine, the standard medicine, or a placebo?
- Do you understand that there will be other medical criteria to meet, which the study team will discuss with you?
What does participation involve?
If you decide to take part in this study, you'll be assigned to receive either the new medicine (Aficamten) or a standard medicine (Metoprolol), or a dummy pill (placebo). Neither you nor your study doctor will know which one you are receiving – this is called 'double-blind' and helps ensure fair results. You will take the assigned medication regularly.
Over 24 weeks, you'll have several visits to the clinic. During these visits, you'll undergo various assessments. This includes a special exercise test to measure your oxygen uptake, questionnaires about your symptoms and quality of life, and heart scans to check changes in your heart's size and function. You'll also have blood tests. The total duration of active participation receiving study medication and having assessments will be 24 weeks.
Potential risks and benefits
Locations (7)
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedFrance
Common questions
What is symptomatic obstructive hypertrophic cardiomyopathy?
It's a heart condition where the heart muscle thickens, making it harder for blood to flow normally out of the heart, leading to symptoms like shortness of breath.
What is Aficamten?
Aficamten is a new medicine being tested to see if it can improve heart function and symptoms for people with this specific heart condition.
What is Metoprolol?
Metoprolol is a commonly used medication for various heart conditions, including some types of hypertrophic cardiomyopathy. It helps to slow the heart rate and reduce the heart's workload.
Will I know which medicine I'm getting?
No, neither you nor your study doctor will know whether you are receiving Aficamten, Metoprolol, or a placebo. This helps ensure the study results are unbiased.
How long does the study last?
The main part of the study where you take medication and have regular check-ups will last for 24 weeks (about 6 months).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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