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A Study of Danicamtiv for Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy to Test if it Improves Heart Function and Exercise Ability

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study is looking at a condition called dilated cardiomyopathy, which is a disease where the heart muscle becomes weakened and stretched, making it harder for the heart to pump blood effectively. This particular study focuses on people who have this condition because of changes in their genes that they were born with or that run in their family. The treatment being tested is called danicamtiv, which is also known by the code names BMS-986434 and MYK-491. Some people in the study will receive danicamtiv tablets while others will receive placebo tablets.

The purpose of this study is to find out if danicamtiv can help improve heart function and exercise ability in people with this genetic form of heart muscle disease. The study is divided into two parts. In the first part, the researchers will use a heart imaging test called transthoracic echocardiogram, which is an ultrasound of the heart, to see if the medication affects how well the heart works. In the second part, they will use cardiopulmonary exercise testing, which measures how much oxygen the body uses during exercise, to see if the medication helps people exercise better. The study will measure these changes over a period of 26 weeks.

During the study, participants will take either danicamtiv or placebo tablets by mouth for up to 26 weeks. The study uses a method where neither the participants nor the doctors know who is receiving the actual medication and who is receiving the placebo. Participants will need to attend regular visits where they will have heart ultrasounds and exercise tests to check how their heart is functioning and how well they can exercise. The study is looking at people who are at least 18 years old and have symptoms of this genetic heart condition with an enlarged left side of the heart.

The research process

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

  1. Step 1

    Initial assessment and baseline measurements

    At the start of the study, your heart function will be assessed using a transthoracic echocardiogram. This is an ultrasound test that creates images of your heart to see how well it is working.

    Your exercise capacity will be measured through cardiopulmonary exercise testing. During this test, you will perform exercise on a stationary bike or treadmill while your oxygen consumption and heart function are monitored.

    These initial measurements will serve as your baseline, which means they will be used to compare against later results during the study.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either danicamtiv tablets or placebo tablets. The placebo tablets look identical to the danicamtiv tablets but do not contain the active substance.

    Neither you nor your doctor will know which treatment you are receiving. This is called a double-blind study and helps ensure accurate results.

    All tablets will be taken by mouth.

  3. Step 3

    Treatment period

    You will take your assigned tablets as directed throughout the treatment period.

    The study is divided into two parts. Part 1 focuses on assessing heart function, and Part 2 evaluates exercise capacity.

    You will continue taking the medication according to the schedule provided by the study team.

  4. Step 4

    Week 26 assessment

    At week 26, you will undergo the same tests that were performed at the beginning of the study.

    A transthoracic echocardiogram will be performed to measure changes in your left atrial function index. The left atrium is one of the chambers of your heart, and this measurement helps determine how well it is functioning.

    Your exercise capacity will be tested again using cardiopulmonary exercise testing to measure your peak oxygen consumption. This shows the maximum amount of oxygen your body can use during intense exercise.

    These results will be compared to your baseline measurements to determine the effect of the treatment.

  5. Step 5

    Follow-up period

    After completing the treatment period, you will enter a follow-up phase.

    If you are sexually active, you must continue using one of the highly effective birth control methods for 3 months after taking your last dose of the study medication.

    Additional assessments may be conducted during this period as specified by the study protocol.

Who can join the trial?

10 criteria

  • You must be 18 years of age or older at the time of the screening visit
  • You must have a diagnosis of dilated cardiomyopathy, which is a condition where the heart becomes enlarged and weakened, caused by specific genetic changes in genes such as MYH7, TTN, or other identified genetic variants, or have a family history of this heart condition
  • You must have New York Heart Association Class II to IV symptoms, which is a way doctors classify how much your heart condition limits your physical activity, ranging from slight limitation to severe limitation, and these symptoms must be stable for at least 1 month
  • You must have at least mild left ventricular enlargement, which means the main pumping chamber of your heart is larger than normal, confirmed by specific measurements on an ultrasound of the heart, and the ultrasound images must be clear enough for accurate assessment
  • You must have chronic dilated cardiomyopathy, meaning your heart condition is long-lasting and not caused by temporary or reversible conditions such as thyroid problems, infections, irregular fast heartbeats, or iron buildup
  • Your heart condition must not be caused by substance abuse, amyloidosis (a condition where abnormal proteins build up in organs), sarcoidosis (an inflammatory disease), or any other secondary form of heart muscle disease
  • You must have a normal heart rhythm, stable pacing from a device, or occasional irregular heartbeat that is well-controlled, to allow proper heart ultrasound assessments
  • You must be able to perform an upright exercise test that measures how well your heart and lungs work during physical activity, with results showing your peak oxygen consumption is 80% or less of what is expected for a healthy person, and meeting specific breathing measurement requirements
  • If you are sexually active, you must use highly effective birth control methods from the screening visit until 3 months after your last dose of the study medication
  • You must be able to understand and follow the study procedures, understand the risks involved, and provide written consent before any study procedures begin

Who cannot join the trial?

5 criteria

  • The study document does not provide specific exclusion criteria, which are the reasons why a patient cannot participate in this clinical trial.
  • If you are interested in this study, the research team would need to evaluate your individual medical situation to determine if you meet all requirements for participation.
  • General factors that often prevent participation in heart studies may include other serious medical conditions, certain medications you are taking, recent heart procedures, pregnancy or plans to become pregnant, or inability to perform required tests.
  • The study involves testing a medication called danicamtiv in patients with a specific heart condition called dilated cardiomyopathy, which is a condition where the heart muscle becomes weakened and enlarged, often passed down in families.
  • The study will use special heart imaging tests called echocardiograms, which use sound waves to create pictures of your heart, and exercise tests that measure how well your heart and lungs work during physical activity.
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Investigated drugs

  • Danicamtiv

    is an investigational medication being studied for the treatment of dilated cardiomyopathy, a condition where the heart muscle becomes weakened and enlarged, making it difficult for the heart to pump blood effectively. This medication is designed to help improve how the heart muscle contracts and functions. In this study, researchers want to see if danicamtiv can improve heart function and increase the ability of patients to exercise.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of danicamtiv against no active treatment, helping researchers determine if the medication truly works.

What is already known about the treatment

Danicamtiv – Danicamtiv is an investigational medication currently being studied in clinical trials for the treatment of symptomatic genetic and familial dilated cardiomyopathy, a condition where the heart muscle becomes weakened and enlarged, making it difficult to pump blood effectively. This drug works at the molecular level by directly affecting the heart muscle cells, specifically targeting the proteins responsible for heart muscle contraction to help improve the heart's pumping ability. The medication is being evaluated to determine if it can enhance cardiac function and improve patients' ability to exercise, which are important measures of heart health and quality of life in people with this inherited heart condition.

Investigated diseases

Dilated Cardiomyopathy – Dilated cardiomyopathy is a heart muscle disease where the heart's main pumping chamber becomes enlarged and weakened. The left ventricle stretches and becomes thinner, making it harder for the heart to pump blood effectively throughout the body. As the condition progresses, the heart muscle loses its ability to contract properly, leading to reduced blood flow to organs and tissues. This can result in fluid buildup in the lungs, legs, and other parts of the body. The heart may also develop irregular rhythms as it tries to compensate for its weakened pumping ability. When the disease has a genetic or familial origin, it means it runs in families and is passed down through inherited genes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-522553-19-00Protocol codeDAN-301Estimated enrolment332 patientsSponsorKardigan Inc.

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