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Study on Danicamtiv for Patients with Primary Dilated Cardiomyopathy Due to MYH7 or TTN Gene Variants

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a heart condition known as Primary Dilated Cardiomyopathy, which is a type of heart failure where the heart becomes enlarged and cannot pump blood efficiently. This condition can be caused by genetic mutations, specifically in the MYH7 or TTN genes, or other causes. The study is testing a new treatment called Danicamtiv, which is taken as a tablet by mouth. Danicamtiv is being developed to help improve heart function in people with this condition.

The purpose of the study is to explore the safety and initial effectiveness of Danicamtiv in patients who are stable and able to walk around. Participants will receive Danicamtiv and will be monitored for any side effects and changes in their heart function. The study will last for a period of time, during which participants will take the medication and have regular check-ups to assess their heart health.

Throughout the study, participants will have their heart function evaluated using tests like echocardiograms, which are ultrasound tests that look at how well the heart is working. The study aims to gather information on how well Danicamtiv is tolerated and its potential benefits for improving heart function in people with Primary Dilated Cardiomyopathy due to genetic mutations or other causes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments may include a review of your medical history, a physical examination, and specific tests to evaluate your heart function.
You will be asked to provide written informed consent, which means you agree to participate in the study after understanding the procedures and potential risks involved.
Step 2
Baseline assessments
Baseline assessments will be conducted to gather initial data about your health status. This includes tests such as echocardiograms, which are ultrasound tests to check your heart's structure and function.
These assessments help establish a starting point for measuring any changes that occur during the trial.
Step 3
Medication administration
You will begin taking the study medication, danicamtiv, in the form of a coated or uncoated tablet. The medication is taken orally, meaning you will swallow it.
The dosage, frequency, and duration of administration will be explained to you by the study team. It is important to follow the instructions provided to ensure the effectiveness and safety of the treatment.
Step 4
Regular follow-up visits
Throughout the study, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the medication.
During these visits, you may undergo various tests, such as blood tests, heart function tests, and physical examinations, to ensure your safety and to assess the medication's impact.
Step 5
Final visit
At the end of the study, you will have a final visit. This visit will include a comprehensive assessment of your health and a review of your experience during the trial.
The study team will discuss the next steps with you, including any follow-up care or additional treatments that may be necessary.

Who can join the trial?

11 criteria

Must be between 18 and 80 years old.
Must be able to understand the study procedures and risks, and provide written consent to participate.
Must have a diagnosis of Primary Dilated Cardiomyopathy (DCM) due to specific genetic variants (MYH7 or TTN) or other causes.
Must not have DCM caused by long-standing hypertrophic cardiomyopathy or left ventricle noncompaction cardiomyopathy.
If DCM is related to TTN variants, it must not be due to pregnancy-related heart issues, exposure to certain chemotherapy drugs, or significant alcohol abuse.
Must have a left ventricular ejection fraction (LVEF) between 15% and 45%, which measures how well the heart pumps blood.
Must be on stable medication for heart failure, such as beta-blockers or ACE inhibitors, unless not tolerated.
Must have a stable heart rhythm or controlled atrial fibrillation.
If multiple family members are eligible, only up to three can participate.
Men must use a barrier method of contraception.
Women of childbearing potential must not be pregnant or breastfeeding and must use effective birth control methods.

Who cannot join the trial?

8 criteria

Patients with a history of severe allergic reactions to the study medication cannot participate.
Patients who have had a heart attack in the last 6 months are not eligible.
Patients with uncontrolled high blood pressure are excluded.
Patients with severe liver disease cannot take part in the study.
Patients with severe kidney disease are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial are excluded.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.

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Verified sites

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Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Spain
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Hospital Universitario da A Coruna
A Coruna Galicia, Spain
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Universitaetsklinikum Heidelberg AöR
Heidelberg, Germany

Trial locations

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Investigated drugs

Danicamtiv is a medication being studied for its potential to help people with a heart condition called dilated cardiomyopathy. This condition affects the heart's ability to pump blood effectively. Danicamtiv works by helping the heart muscle contract more strongly, which may improve the heart's function. The trial is exploring how safe and tolerable this medication is for people with specific genetic forms of this heart condition, as well as other causes. Participants in the trial are monitored to see how their heart responds to the treatment and to check for any side effects.

Danicamtiv

What is already known about the treatment

Danicamtiv – Danicamtiv is administered orally and is currently being studied in clinical trials to assess its safety and effectiveness. It is primarily being investigated for its potential to treat primary dilated cardiomyopathy, a condition affecting the heart muscle, particularly in patients with specific genetic variants like MYH7 or TTN. The medication works by enhancing the function of cardiac myosin, a protein that plays a crucial role in heart muscle contraction, thereby improving heart function. Danicamtiv is classified as a cardiac myosin activator, a type of drug that aims to improve heart performance by directly affecting the heart muscle's contractile machinery.

Investigated diseases

Primary Dilated Cardiomyopathy Due to Either MYH7 or TTN Variants – This condition is a type of heart muscle disease where the heart's main pumping chamber, the left ventricle, becomes enlarged and weakened. It is caused by genetic mutations in the MYH7 or TTN genes. As the disease progresses, the heart's ability to pump blood effectively is reduced, leading to symptoms such as fatigue and shortness of breath. Over time, the heart may struggle to maintain normal blood circulation, affecting the body's organs and tissues. The heart's structure and function can continue to deteriorate, potentially leading to complications. The disease primarily affects the heart's systolic function, which is the phase of the heartbeat when the heart muscle contracts and pumps blood.