AN OPEN-LABEL, EXPLORATORY STUDY OF THE SAFETY AND PRELIMINARY EFFICACY OF DANICAMTIV IN STABLE AMBULATORY PARTICIPANTS WITH PRIMARY DILATED CARDIOMYOPATHY DUE TO EITHER MYH7 OR TTN VARIANTS OR OTHER CAUSALITIES
This research study is testing a new medicine called Danicamtiv for people who have a heart condition known as primary dilated cardiomyopathy. This condition means the heart muscle becomes stretched and thin, making it harder for the heart to pump blood effectively. This particular study focuses on people whose condition is caused by changes in certain genes (MYH7 or TTN) or other reasons. We are looking closely at whether Danicamtiv is safe to use and if it has any helpful effects on the heart. It's an early-stage study, meaning we are still exploring how the medicine works and if it could be a useful treatment in the future. We'll be checking participants' overall health very carefully.
At a glance
What is this study about?
This study is about a heart condition called dilated cardiomyopathy. In simple terms, this means your heart muscle has become stretched and thinner than it should be, making it harder for your heart to pump blood around your body. This can lead to symptoms like tiredness, breathlessness, and swelling in your legs.
We are looking at a new medicine called Danicamtiv. The main goal of this study is to find out if Danicamtiv is safe for people with this heart condition and to see if it has any positive effects on how the heart works. This is an important step because it helps us understand if this medicine could be a good treatment option in the future. We're especially interested in people whose dilated cardiomyopathy is linked to specific genetic changes (called MYH7 or TTN variants) or other causes.
During the study, we will keep a very close eye on your health and check for any side effects the medicine might cause. We will also perform various tests to see if the medicine helps improve your heart's ability to pump blood. This includes looking at the size and strength of your heart through scans. Your safety and well-being are our top priorities throughout this research.
Key takeaways
- This study tests a new medicine called Danicamtiv for dilated cardiomyopathy.
- It aims to check the medicine's safety and if it helps the heart pump better.
- The study focuses on people whose heart condition is stable and possibly genetic.
- Regular health checks, blood tests, and heart scans will be part of participation.
- You can stop participating at any time.
- The findings could help improve future treatments for this heart condition.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. Both men and women are welcome to take part.
You should have a diagnosis of primary dilated cardiomyopathy. This means your heart muscle is stretched and weakened. We're looking for people whose condition is stable, meaning it's not getting worse quickly, and you should be able to walk around on your own.
It's important that your dilated cardiomyopathy is due to specific genetic changes like MYH7 or TTN variants, or other known causes of this condition. Your doctors will check if you meet all the necessary health requirements to ensure the study is right for you and safe.
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 primary dilated cardiomyopathy?
- Is your heart condition currently stable?
- Can you walk around easily without needing assistance?
- Has your doctor confirmed your condition is due to MYH7, TTN genes, or another specific cause?
- Are you able to attend regular clinic appointments for checks and tests?
What does participation involve?
If you decide to take part in this study, you will be given the medicine, Danicamtiv. This is an 'open-label' study, which means both you and the study doctors will know you are receiving the active medicine. The study has different parts, and we will closely monitor your health throughout. This will involve regular visits to the clinic where we will perform several assessments. These include checking your vital signs (like blood pressure and heart rate), doing physical examinations, taking ECG recordings (to check your heart's electrical activity), and collecting blood samples for safety tests. We will also use special heart scans, called echocardiograms, to see how your heart muscle and blood flow are responding to the medicine. The total duration of your participation, including follow-up, will be explained by the study team.
Potential risks and benefits
Locations (2)
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Common questions
What is dilated cardiomyopathy?
It's a heart condition where the heart muscle becomes stretched and weakened, making it harder for your heart to pump blood effectively.
What is Danicamtiv?
Danicamtiv is the new medicine being tested in this study to see if it's safe and helps people with dilated cardiomyopathy.
Will I know if I'm getting the medicine?
Yes, this is an 'open-label' study, which means you and the doctors will both know you are receiving Danicamtiv.
Why are you looking at MYH7 or TTN genes?
These are specific genetic changes that can cause dilated cardiomyopathy, and the study is interested in how Danicamtiv might affect people with these particular causes.
How long will I be in the study?
The study team will provide you with the exact duration of your participation, including all visits and follow-up appointments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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