Not yet recruitingPHASE3INTERVENTIONAL

A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

This study is investigating a new medicine called Danicamtiv for adults who have a heart condition known as genetic or familial Dilated Cardiomyopathy (DCM) and are experiencing symptoms. DCM makes the heart muscle stretched and thin, making it harder to pump blood. There are currently no approved medicines specifically for genetic or familial DCM, so this research is very important. The study wants to find out how effective Danicamtiv is over a long period, typically up to five years, and whether it is safe for people to use regularly. Participants will take the medicine twice a day and have regular check-ups to monitor their health and the medicine's effects. It's a 'Phase 3' study, meaning it's a large trial testing a medicine that has already shown promise in earlier research.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Kardigan, Inc.

Enrolment target

332

Start

01 Aug 2026

Estimated completion

01 Jan 2033

Symptomatic Genetic Dilated Cardiomyopathy (DCM)

What is this study about?

You're looking at information about a clinical trial for a heart condition called genetic or familial Dilated Cardiomyopathy (DCM). This is a condition where the heart muscle becomes stretched and thin, making it harder for the heart to pump blood around your body. It's called 'genetic' or 'familial' because it's often passed down in families.

This study is testing a new medicine called Danicamtiv. It's an 'investigational medication,' which means scientists are still studying it, and it's not yet available as a standard treatment. The main goal of this trial is to understand how well Danicamtiv works over a long time – up to five years – to help people with DCM. They also want to check how safe it is and if people can take it without too many side effects. This research is important because, right now, there aren't any medicines made specifically to treat genetic or familial DCM.

By taking part, you would be helping doctors and researchers learn more about how to manage this condition. The study aims to see if regular use of Danicamtiv can lead to lasting benefits and whether it's a good treatment option for people with this type of heart disease.

Key takeaways

This study is for a new medicine (Danicamtiv) for genetic or familial Dilated Cardiomyopathy (DCM).
Danicamtiv is an unapproved medicine, meaning it's still being tested for safety and effectiveness.
The study will last up to 5 years, with 16 clinic visits for health checks.
It's a long-term study to see how well Danicamtiv works and if it's safe over time.
There are currently no specific approved medicines for genetic/familial DCM.
You can stop participating in the study at any time.

Who may be eligible?

To join this study, you first need to have already taken part in an earlier study called DAN-301 and completed its first or second stage, including all the planned health checks. This is because this new study is a long-term follow-up to that previous research.

If you are a woman who could become pregnant and are sexually active, you must use a very reliable form of birth control from the moment you start the study until three months after you take your last dose of the study medicine. This is to ensure safety as we don't yet know the full effects of the medicine.

It's also important that you understand what's involved in the study, including any possible risks. You'll need to be able to follow the study's instructions and give your written permission (called 'informed consent') to take part before any study-related procedures begin. This ensures you are happy and fully understand everything before deciding to join.

There are also some reasons why you might not be able to join. For example, if you've recently had a heart attack, an operation on your heart's blood vessels, or a hospital stay for heart failure, you might not be eligible. Also, if you've had a stroke or a serious infection that needed hospital treatment recently, or if you have certain cancers that could affect your survival, you would not be able to participate. These rules are in place to keep participants safe and make sure the study results are clear.

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.

Have I already taken part in the DAN-301 study and completed its first or second part?
If I am a woman of childbearing age, am I willing to use highly effective birth control during and for 3 months after the study?
Am I able to understand the study information and give my written consent?
Have I had any recent heart attacks, heart operations, hospital stays for heart failure, or a stroke in the last 3 months?
Have I had a recent serious infection that needed hospital treatment (in the last 30 days)?
Do I have any cancers that could significantly shorten my life?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to:

* **Take the study medicine:** You would take the new medicine, Danicamtiv, twice a day, every day. This could be for quite a long time, up to five years. * **Attend clinic visits:** You'd need to visit the clinic about 16 times over the course of the study. These visits are for health checks and tests to see how you're doing and how the medicine is affecting you. * **Undergo assessments:** At these visits, you would have various evaluations and tests. These might include checking your heart health, blood tests, and other procedures to monitor your condition and the effects of Danicamtiv. * **Total duration:** The study is designed to run for up to five years, meaning your involvement could last that long.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. A potential benefit of this study is that the new medicine, Danicamtiv, might help manage your genetic or familial Dilated Cardiomyopathy, and you would receive close medical attention and monitoring throughout the study. However, like all medicines, Danicamtiv may have side effects, and it's not yet known if it will definitely help or if it's completely safe in the long term. There's also the chance that it might not work for you. It's very important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (78)

University of Alabama Birmingham
Verified postcode
Birmingham, United States
Cedars Sinai
Verified postcode
Los Angeles, United States
University of California, Los Angeles (UCLA) - David Geffen School of Medicine
Verified postcode
Los Angeles, United States
University of California, San Diego (UCSD) - Medical Center
Verified postcode
San Diego, United States
University of California, San Francisco (UCSF)
Verified postcode
San Francisco, United States
Stanford University Medical Center
Verified postcode
Stanford, United States
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States
Mayo Clinic - Jacksonville
Verified postcode
Jacksonville, United States
Northwestern University
Verified postcode
Chicago, United States
Louisiana State University (LSU) Health Sciences Center
Verified postcode
New Orleans, United States
Johns Hopkins Medicine
Verified postcode
Baltimore, United States
Brigham and Women's Hospital
Verified postcode
Boston, United States

Common questions

What is Dilated Cardiomyopathy (DCM)?

DCM is a heart condition where the heart muscle becomes stretched and thin, making it harder for the heart to pump blood around your body effectively.

Is Danicamtiv already approved for use?

No, Danicamtiv is an investigational medicine, which means it is still being studied and has not yet been approved for general use by health authorities.

How long would I need to take the medicine?

If you take part, you would be asked to take Danicamtiv twice a day for up to five years.

What is a 'Phase 3' study?

A Phase 3 study is a large-scale trial that tests a new medicine on many people to see how well it works and if it's safe, after it has shown promise in earlier, smaller studies.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Kardigan Clinical Trial Information Team

clinicaltrials@kardigan.bio 1-877-310-5135 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.