Frontlight ResearchEarly access
Taking people in United StatesPhase 3
Danicamtiv for long-term use in genetic or familial dilated cardiomyopathy
Tests danicamtiv over a longer time in adults with genetic dilated cardiomyopathy.
Key facts
- Who runs it
- Kardigan, Inc.
- Where
- Baltimore, Birmingham, Boston, Chicago, Cincinnati, Columbus, Detroit, Durham, Houston, Jacksonville, Kansas City, Los Angeles, Minneapolis, Nashville, New Orleans, New York, Omaha, Philadelphia, Portland, Rochester, San Diego, San Francisco, St Louis, Stanford, and Washington D.C., United StatesSee the 28 sitesAlso in 10 other countries, 50 sites
- Trial code
- Registry title
- A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 332 people, planned
- Started
- 26 Aug 2026
- Expected to end
- Jan 2033
- Type of study
- Interventional
- Treatments tested
- Danicamtiv
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with symptomatic genetic or familial dilated cardiomyopathy (an enlarged, weak heart muscle) who finished the earlier DAN-301 study. All participants take danicamtiv, an experimental drug.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Symptomatic genetic or familial dilated cardiomyopathy
- Earlier treatment
- Must have completed 24 weeks of blinded study treatment (the Week 26 Visit) and planned tests in Part 1 or Part 2 of the DAN-301 study.
Main reasons for not taking part
- Acute coronary syndrome, serious blockage of the heart arteries, or a heart artery procedure (PCI or CABG) within 90 days of the DAN-302 Screening Visit
- Hospital stay for heart failure or use of IV diuretic (water pills by drip) in the last 90 days
- Other heart or blood vessel events, such as a stroke, in the last 90 days
- Hospital stay for sepsis or another serious body-wide infection within 30 days of Screening
- Cancer needing treatment after joining DAN-301 that could shorten survival
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Other recent (<90 days) cardiovascular events (e.g., cerebrovascular accident)
Where in United States
Also in 10 other countries, 50 sites
- Johns Hopkins MedicineBaltimore, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- University of Alabama BirminghamBirmingham, United StatesContact: Kardigan Clinical Trial TeamTaking people
- Brigham and Women's HospitalBoston, United StatesContact: Kardigan Clinical Trial TeamTaking people
- Northwestern UniversityChicago, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- The Lindner Center for Research and Education at The Christ HospitalCincinnati, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- The Ohio State University -Wexner Medical CenterColumbus, United StatesContact: Kardigan Clinical Trial TeamTaking people
- Henry Ford Health SystemDetroit, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Duke University Medical CenterDurham, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Baylor College of MedicineHouston, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Houston Methodist HospitalHouston, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Mayo Clinic- JacksonvilleJacksonville, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Saint Luke's Mid America Heart InstituteKansas City, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Cedars SinaiLos Angeles, United StatesContact: Kardigan Clinical Trial TeamTaking people
- University of California, Los Angeles (UCLA) - David Geffen School of MedicineLos Angeles, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- University of MinnesotaMinneapolis, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Vanderbilt University Medical CenterNashville, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Louisiana State University (LSU) Health Sciences CenterNew Orleans, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Columbia University Medical Center/New York-Presbyterian HospitalNew York, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- NYU Langone HealthNew York, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- University of Nebraska Medical CenterOmaha, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- University of PennsylvaniaPhiladelphia, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Oregon Health & Science University (OHSU)Portland, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Mayo Clinic - RochesterRochester, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- University of California, San Diego (UCSD) Medical CenterSan Diego, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- University of California, San Francisco (UCSF)San Francisco, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- Washington University in St. LouisSt Louis, United StatesContact: Kardigan Clinical Trial TeamTaking people
- Stanford University Medical CenterStanford, United StatesContact: Kardigan Clinical Trial TeamNot yet recruiting
- MedStar Washington Hospital CenterWashington D.C., United StatesContact: Kardigan Clinical Trial TeamTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- DanicamtivTreatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
- Plain-language title
- Danicamtiv for long-term use in genetic or familial dilated cardiomyopathyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 4 November 2026