332 Participants Needed

Danicamtiv for Heart Failure

(KINSHIP-DCM Trial)

KC
Overseen ByKardigan Clinical Trial Information Team
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Kardigan, Inc.
Must be taking: Heart failure therapies
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether danicamtiv, an investigational medication, can aid individuals with genetic or familial dilated cardiomyopathy (DCM). DCM weakens and enlarges the heart muscle, hindering effective blood pumping. The study compares danicamtiv to a placebo to assess improvements in heart function and exercise capacity, while monitoring for side effects. Suitable candidates have DCM due to specific genetic changes or a family history of the disease and exhibit stable symptoms. Participants will take the medication or placebo daily and visit the clinic about 12 times over six months. As a Phase 2, Phase 3 trial, this study evaluates danicamtiv's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires participants to be on stable doses of their current heart failure medications for at least 4 weeks before starting. This means you should not stop taking your current medications.

Is there any evidence suggesting that danicamtiv is likely to be safe for humans?

Previous studies have generally shown that patients with heart conditions tolerate danicamtiv well. Research indicates that some participants experienced mild to moderate side effects, such as nausea and dizziness, but these effects were not severe for most. The studies reviewed reported no serious side effects directly linked to danicamtiv. While researchers continue to study danicamtiv, these findings suggest it may be safe for individuals with genetic and familial dilated cardiomyopathy (DCM).12345

Why do researchers think this study treatment might be promising for DCM?

Danicamtiv is unique because it directly targets the way heart muscle fibers contract, which is a different approach compared to most existing heart failure treatments that primarily focus on reducing fluid buildup or controlling blood pressure, like beta-blockers and ACE inhibitors. This drug works by enhancing the function of the cardiac myosin, a key protein involved in heart muscle contraction, potentially leading to improved heart function without increasing heart rate. Researchers are excited about Danicamtiv because it offers a novel mechanism of action that could provide a more targeted and efficient way to boost heart performance in patients with heart failure.

What evidence suggests that danicamtiv might be an effective treatment for genetic and familial DCM?

Research has shown that danicamtiv, a new drug tested in this trial, may benefit people with dilated cardiomyopathy (DCM), a condition where the heart muscle weakens and enlarges. In earlier studies, patients taking danicamtiv experienced improved heart function and found exercise easier. One study found that danicamtiv increased the amount of blood the heart pumped with each beat. In animals with heart failure, danicamtiv also helped the heart empty more effectively with each beat. This drug works by activating a protein called cardiac myosin, which enhances heart muscle contraction. These findings suggest that danicamtiv could be a promising treatment for DCM. Participants in this trial will receive either danicamtiv or a placebo to further evaluate its effectiveness.23467

Are You a Good Fit for This Trial?

This trial is for people with genetic or familial dilated cardiomyopathy (DCM), which makes the heart weak and large. Participants must have a specific diagnosis of DCM, be in NYHA Class II-IV with stable symptoms, able to do an exercise test, have a left ventricular ejection fraction (LVEF) of ≤45%, and be on stable heart failure medications.

Inclusion Criteria

Can perform an upright cardiopulmonary exercise training (CPET) with a peak oxygen uptake (pV̇O2) of 80% or less of predicted for a healthy individual and respiratory exchange ratio (RER) of ≥1.05
My heart condition has been stable for at least a month and is classified as moderate to severe.
I have been on a stable heart failure treatment for at least 4 weeks.
See 4 more

Exclusion Criteria

Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of left ventricle (LV) function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. > 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function
History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation
Clinically significant laboratory abnormalities at Screening
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take danicamtiv or placebo every day for approximately 6 months

26 weeks
12 visits (in-person) for initial evaluation, checkups, tests, and follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Danicamtiv
Trial Overview The study tests danicamtiv against a placebo to see if it improves heart function and exercise capacity in those with DCM. Patients will take either the drug or placebo daily for about 6 months and visit the clinic around 12 times for evaluations, checkups, tests, and follow-ups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: danicamtivExperimental Treatment1 Intervention
Group II: placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kardigan, Inc.

Lead Sponsor

Trials
1
Recruited
700+

Citations

Kardigan Announces Presentation of Positive Phase 2a Data ...... Data for Danicamtiv in Patients with Dilated Cardiomyopathy ... These results, presented in a late-breaking oral session at the Heart Failure ...
Effects of danicamtiv, a novel cardiac myosin activator, in heart ...In dogs with heart failure, danicamtiv improved LV stroke volume (+10.6 mL, P < 0.05) and LA emptying fraction (+10.7%, P < 0.05). In patients ...
New Insights Into Outcomes With Acoramidis in ATTR-CM, ...Danicamtiv, a selective agonist of cardiac myosin, for dilated cardiomyopathy: A Phase 2 open-label trial. JACC. Published online Sept. 29, 2025 ...
Danicamtiv, a selective agonist of cardiac myosin, for ...Heart Failure & Cardiomyopathies. Keywords. Dilated cardiomyopathy ... cardiovascular medicine and improve heart patient outcomes. Read ...
Danicamtiv Recruits Myosin Motors to Aid the Failing HeartDanicamtiv is another myotrope that has been proposed as treatment for heart failure, based on promising preclinical and early clinical studies ...
NCT07210723 | A Study of the Efficacy and Safety ...A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM).
Danicamtiv, a selective agonist of cardiac myosin, for ...Condensed abstract: Dilated cardiomyopathy (DCM) leads to cardiac failure due to progressive ventricular and atrial remodeling. Danicamtiv is an ...
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