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Long‑Term Safety and Efficacy Study of Danicamtiv in Adults with Symptomatic Genetic and Familial Dilated Cardiomyopathy

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study focuses on adults who have symptomatic genetic and familial Dilated Cardiomyopathy, a condition in which the heart’s main pumping chamber becomes enlarged and weakened, leading to reduced heart function. Participants will receive the investigational medication Danicamtiv, which is taken by mouth as a tablet. The purpose of the study is to evaluate the long‑term safety and tolerability of this drug in the target population.

During the trial, participants will attend regular visits where basic health checks, such as blood pressure and heart rate measurements, are performed, and a simple heart test called a 12‑lead ECG (a recording of the heart’s electrical activity) is done. Blood samples will also be taken to measure troponins, proteins that can signal damage to the heart muscle. The study will continue for an extended period, allowing researchers to monitor any side effects or health changes that may arise while participants continue the medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial enrollment and consent

    After you join the study, you will sign a consent form that explains what will happen during the trial.

    The study team will confirm that you meet the eligibility criteria for symptomatic genetic and familial dilated cardiomyopathy.

  2. Step 2

    Baseline health assessments

    You will undergo a physical examination, measurement of vital signs (such as blood pressure and heart rate), and a 12‑lead ecg to record the electrical activity of the heart.

    Blood samples will be taken for laboratory tests, including measurement of troponins, which are proteins that can indicate heart muscle injury.

    These assessments establish a reference point before you start taking the study medication.

  3. Step 3

    Start of study medication

    You will begin taking danicamtiv, an oral tablet designed for long‑term use in this condition.

    The tablet dose is listed as 00 mg; the exact amount and schedule will be provided by the study staff and must be followed exactly as instructed.

    The medication will be taken for the entire duration of the study, which may extend up to the planned end date of 2032‑11‑06.

  4. Step 4

    Regular follow‑up visits

    You will return to the study site at scheduled intervals for repeat physical exams, vital sign checks, and 12‑lead ecg recordings.

    Additional blood tests, including troponin measurements, will be performed to monitor safety.

    The frequency of these visits will be defined by the study protocol and communicated to you in advance.

  5. Step 5

    Monitoring and reporting of side effects

    Any new symptoms, discomfort, or health changes you experience are considered potential adverse events and should be reported to the study team promptly.

    The study will track the frequency and severity of these events, as well as any serious health events related to the disease.

  6. Step 6

    Final assessment and study completion

    At the end of the study period, you will undergo a final set of examinations similar to the baseline assessments.

    The study team will evaluate the long‑term safety and tolerability of danicamtiv based on all collected data.

Who can join the trial?

4 criteria

  • Be at least 18 years old at the time of the screening visit.
  • Have finished 24 weeks of blinded study treatment (meaning you took the study medication without knowing which version it was) and be scheduled for the follow‑up assessments in either Part 1 or Part 2 of the study.
  • Use birth control that follows local rules; if you are sexually active, you must use a highly effective method of contraception from the screening visit until three months after the last dose of the study drug.
  • Be able to understand and follow the study procedures, understand the risks, and sign a written informed consent form before any study‑specific actions are taken.

Who cannot join the trial?

22 criteria

  • You have had a heart attack (also called acute coronary syndrome), a serious blockage of the main heart arteries that affects blood flow (hemodynamically significant epicardial coronary disease), or a procedure to open those vessels (coronary revascularization) within the last 90 days.
  • You were hospitalized for worsening heart failure or needed strong fluids that remove excess water (intravenous diuretics) within the last 90 days.
  • You have had another serious heart or blood‑vessel problem, such as a stroke (cerebrovascular accident), within the last 90 days.
  • You were hospitalized for sepsis (a severe whole‑body infection) or another serious infection within the past 30 days.
  • You have cancer that needs treatment and could affect your survival.
  • You have very poor kidney function (severe renal insufficiency).
  • You have another serious medical condition that could affect the study.
  • You are expected to receive a heart transplant within the next six months.
  • You have planned a cardiac resynchronization therapy (a device that helps the heart beat in sync) or other major surgery within six months.
  • You currently have, or will have in the next six months, a ventricular assist device (a pump that helps the heart move blood).
  • You took part in another drug study (other than this one) and received a test drug or used a test device within 30 days, or before the drug has cleared from your body (usually about five times the time it takes for half the drug to leave, called the elimination half‑life).
  • Your blood potassium level is outside the range allowed by the study.
  • You have two or more lab test results that are abnormal and could be unsafe.
  • Your hemoglobin (the protein that carries oxygen in your blood) is outside the allowed range.
  • You have a current liver disease.
  • Your thyroid‑stimulating hormone (a test of thyroid function) is outside the allowed range.
  • Your blood creatine kinase (an enzyme that can rise with muscle damage) is outside the allowed range.
  • You are allergic to danicamtiv or any ingredient in the medication.
  • Your doctor expects you to live less than six months.
  • You are pregnant or are nursing a baby.
  • You are taking medicines that are not allowed in this study.
  • You work for, or are a close family member of, someone who works for the study sponsor or investigators.
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Investigated drugs

Danicamtiv is an oral tablet being studied as a possible treatment for adults who have genetic or family‑related dilated cardiomyopathy, a condition where the heart becomes enlarged and weak. In this long‑term open‑label extension study, participants take Danicamtiv to see how safe it is when used for many months and whether it helps the heart work better and reduces symptoms. Researchers will closely watch for any side effects, check heart function, and assess overall health while participants continue the medication.

What is already known about the treatment

Danicamtiv - Danicamtiv is taken as an oral tablet that patients swallow. It is still an investigational drug being studied in clinical trials and is not yet approved for general use. It is being tested for people with symptomatic genetic or familial dilated cardiomyopathy, a condition where the heart becomes enlarged and weak. The medicine works by directly activating cardiac myosin, the protein that helps heart muscle cells contract, which improves the heart’s pumping ability, and it belongs to the class of cardiac myosin activators.

Investigated diseases

Dilated cardiomyopathy - Dilated cardiomyopathy is a condition where the heart’s main pumping chambers become enlarged and weakened. In genetic or familial forms, the problem is inherited and often appears in younger people. The heart walls stretch, reducing the ability to contract efficiently. Over time, the heart may fill with more blood than it can pump out, leading to fluid buildup in the lungs or legs. Symptoms such as shortness of breath, fatigue, and swelling may gradually worsen as the disease progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526139-20-00Protocol codeDAN-302Estimated enrolment332 patientsSponsorKardigan Inc.

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