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A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Study acronym: KINSHIP-DCM
StatusRecruiting
PhasePhase 2/3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 3 of 14 entries
    • Site details revised at 14 of 78 sites
  2. Trial sites expanded: 56 → 78 locationsv14
  3. Trial sites expanded: 43 → 56 locationsv13
  4. Trial sites expanded: 33 → 43 locations
    • Study sites revised (43)
    v12
  5. Study sites: 33 to 43v11
  6. Trial sites expanded: 26 → 33 locationsv10
  7. Study sites: 18 to 26v9
  8. Study sites: 11 to 18
    • Start date changed from estimate of Feb 2026 to Feb 13, 2026
    v8
  9. Study sites: 9 to 11
    • Start date: Jan 2026 to Feb 2026
    v7
  10. Study sites: 7 to 9v6
  11. Study sites: 2 to 7
    • Start date: Dec 2025 to Jan 2026
    v5
  12. Study sites: 1 to 2
    • Start date: Nov 2025 to Dec 2025
    v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  14. Eligibility criteria shortened, about 6 wordsv2
  15. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM. The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM). The main goals of the study are: * To assess the effect of danicamtiv on cardiac function using echocardiogram. * To evaluate the impact of danicamtiv on exercise capacity * To evaluate the safety and tolerability of danicamtiv Participants will: * Take danicamtiv or placebo every day for approximately 6 months * Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up
Trial Details
NCT Number NCT07210723
Lead Sponsor Kardigan, Inc.
Conditions
(from sponsor)		 Symptomatic Genetic Dilated Cardiomyopathy
Enrollment 332 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov