NCT07771465 · Kardigan, Inc.
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
(KINSHIP-OLE)
What this study is about
Danicamtiv is an experimental medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used in patients with genetic or familial dilated cardiomyopathy (DCM). There are currently no approved medicines made specifically to treat genetic or familial DCM.
View original scientific description
Danicamtiv is an investigational medication, which means it is still being studied and has not been approved. The purpose of this study is to learn how well danicamtiv works, how safe it is, how well people can take it when used in patients with genetic or familial dilated cardiomyopathy (DCM). There are currently no approved medicines made specifically to treat genetic or familial DCM.
Interventions
DRUG
Danicamtiv
Danicamtiv will be administered twice daily for up to 5 years
Primary outcome measures
Frequency and severity of treatment-emergent adverse events (TEAEs)
Time frame: 61 months
Frequency and severity of adverse events of special interest (AESIs)
Time frame: 61 months
Frequency and severity of serious adverse events (SAEs)
Time frame: 61 months
Frequency and severity of disease-related events (DREs)
Time frame: 61 months
Frequency of abnormal findings from physical examination
Time frame: 61 months
Frequency of abnormal findings from vital signs
Time frame: 61 months
Frequency of abnormal findings from 12-lead electrocardiograms (ECGs)
Time frame: 61 months
Frequency of abnormal findings from clinical laboratory assessments
Time frame: 61 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Completed 24 weeks of blinded study treatment (corresponding to the Week 26 Visit in DAN-301) and planned assessments in Part 1 or Part 2 of the DAN-301 study.
- If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
- Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.
Exclusion criteria
- Acute coronary syndrome or hemodynamically significant epicardial coronary disease, or coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\]) performed within 90 days of DAN-302 Screening Visit.
- Recent (\<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
- Other recent (\<90 days) cardiovascular events (e.g., cerebrovascular accident).
- Hospitalization for sepsis or other systemic infections within 30 days of Screening. A systemic infection includes suspected or confirmed infection associated with fever, hemodynamic instability, bacteremia, or organ dysfunction typically requires urgent evaluation and/or acute care.
- Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.
Where
- Birmingham, Alabama
- Los Angeles, California
- San Diego, California
- San Francisco, California
- Stanford, California
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Chicago, Illinois
- New Orleans, Louisiana
- Baltimore, Maryland
- Boston, Massachusetts
- Detroit, Michigan
And 13 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2026 · Source of record for eligibility and locations