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Taking people in United KingdomPhase 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
Bristol, Glasgow, Leicester, London, and Oxford, United KingdomSee the 8 sitesAlso in 10 other countries, 70 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 Kingdom

Also in 10 other countries, 70 sites

  • University Hospitals Bristol NHS Foundation TrustBristol, United KingdomContact: Kardigan Clinical Trial TeamNot yet recruiting
  • NHS Greater Glasgow and ClydeGlasgow, United KingdomContact: Kardigan Clinical Trial TeamNot yet recruiting
  • Glenfield HospitalLeicester, United KingdomContact: Kardigan Clinical Trial TeamNot yet recruiting
  • Hammersmith Hospital, Imperial College of LondonLondon, United KingdomContact: Kardigan Clinical Trial TeamTaking people
  • Royal Brompton HospitalLondon, United KingdomContact: Kardigan Clinical Trial TeamTaking people
  • St. Bartholomew's HospitalLondon, United KingdomContact: Kardigan Clinical Trial TeamNot yet recruiting
  • St. George's HospitalLondon, United KingdomContact: Kardigan Clinical Trial TeamNot yet recruiting
  • Cardiovascular Clinical Research Facility (CCRF)Oxford, United KingdomContact: Kardigan Clinical Trial TeamNot yet recruiting

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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