A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
This research study is looking into a new medication called danicamtiv for people who have dilated cardiomyopathy (DCM) that runs in their family or is caused by a genetic change. DCM makes the heart muscle weaker and larger, making it harder for the heart to pump blood. Currently, there aren't many specific treatments for this type of DCM. The study wants to find out if danicamtiv is effective in improving heart function and exercise ability, and if it's safe to use. Half the participants will get danicamtiv, and the other half will get a placebo (a dummy pill). You would take the medication daily for about six months and attend around 12 clinic visits for checks and tests.
At a glance
What is this study about?
This study is checking a new medicine called danicamtiv for people who have a heart condition called dilated cardiomyopathy (DCM). DCM means your heart muscle has become stretched and weakened, making it harder for your heart to pump blood effectively around your body. This can lead to symptoms like breathlessness and tiredness. There are different reasons why people develop DCM, but this study is focusing on those whose DCM is either caused by a specific gene change (called 'genetic DCM') or runs in their family ('familial DCM'), even if the exact gene isn't found.
At the moment, there aren't any specific approved medicines designed just for genetic or familial DCM. This means doctors often use treatments that help with the general symptoms of heart failure. This study wants to see if danicamtiv can make a real difference in how well the heart pumps and how much physical activity people can manage. It also carefully checks if the medicine is safe and if people can take it without too many side effects.
To figure this out, some people in the study will take danicamtiv, and others will take a 'placebo', which looks exactly like the real medicine but doesn't contain any active drug. This helps the researchers truly understand if any improvements are due to danicamtiv itself, rather than other factors. They will use scans like echocardiograms (heart ultrasound) to measure heart function and will also look at exercise tests to see if people's ability to be active improves.
Key takeaways
- This study is for people with genetic or familial dilated cardiomyopathy (DCM).
- It's testing a new medicine called danicamtiv against a dummy pill (placebo).
- The main goals are to check if danicamtiv improves heart function and exercise ability, and if it's safe.
- Participation involves taking daily medication for ~6 months and attending ~12 clinic visits.
- The study aims to find a specific treatment for this type of DCM.
Who may be eligible?
This study is looking for adults aged 18 or over. You might be able to take part if you have a diagnosis of DCM that is caused by specific gene changes or runs in your family. Your heart failure symptoms should be stable, and you should be on your usual heart failure medications at a steady dose for at least one month.
However, you won't be able to join if your heart failure is mainly caused by other issues like blocked blood vessels (heart attacks), problems with heart valves, or other specific medical conditions. You also can't have had a recent major heart event or surgery in the last three months. Certain irregular heart rhythms that make it hard to measure heart function would also prevent you from joining.
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 dilated cardiomyopathy (DCM) that is genetic or runs in your family?
- Are your heart failure symptoms stable, and have you been on your usual heart medicines for at least a month?
- Do you not have DCM caused by other problems like heart attacks, valve disease, or heavy alcohol use?
- Have you avoided any major heart events or surgeries in the last three months?
What does participation involve?
If you decide to take part in this study, you would either receive the study medication (danicamtiv) or a placebo (a dummy pill) to take every day for about six months. Over this six-month period, you would need to visit the clinic approximately 12 times. These visits will involve various checks and tests, such as heart scans (echocardiograms), exercise tests, and blood tests, to see how your heart is working and how you are feeling. There will be an initial assessment, regular check-ups, and a final follow-up. The total duration of your active participation will be around six months, with some follow-up after that.
Potential risks and benefits
Locations (43)
- University of Alabama BirminghamVerified postcodeBirmingham, United States· Recruiting
- Cedars SinaiVerified postcodeLos Angeles, United States· Recruiting
- University of California, San Diego (UCSD) - Medical CenterVerified postcodeSan Diego, United States· Recruiting
- UCSFVerified postcodeSan Francisco, United States· Recruiting
- MedStar Washington Hospital CenterVerified postcodeWashington D.C., United States· Recruiting
- Mayo Clinic - JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- Northwestern UniversityVerified postcodeChicago, United States· Recruiting
- Louisiana State University (LSU) Health Sciences CenterVerified postcodeNew Orleans, United States· Recruiting
- Brigham and Women's HospitalVerified postcodeBoston, United States· Recruiting
- Henry Ford Health SystemVerified postcodeDetroit, United States· Recruiting
- Mayo Clinic RochesterVerified postcodeRochester, United States· Recruiting
- Washington University in St. LouisVerified postcodeSt Louis, United States· Recruiting
Common questions
What is 'dilated cardiomyopathy'?
It's a condition where your heart muscle becomes weakened and stretched, making it harder for your heart to pump blood effectively.
What does 'investigational medication' mean?
It means the medicine is still being tested to see if it's safe and if it works. It's not yet approved for general use.
Will I know if I'm getting the drug or the placebo?
No, this is a 'blinded' study, meaning neither you nor your study doctor will know whether you're receiving danicamtiv or the placebo. This helps make the study results fair.
What is an echocardiogram?
It's a type of ultrasound scan that uses sound waves to create moving pictures of your heart, showing how well it's pumping.
How long will I be in the study?
You'll take the study medication daily for about six months and have around 12 clinic visits during that time.
How to find out more
Kardigan Clinical Trial Information Team
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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