Phase 3Recruiting
A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-OLE)
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy
- Sponsor
- Kardigan, Inc. (Industry)
- Enrolment
- 332 planned
- Conditions
- Symptomatic Genetic Dilated Cardiomyopathy (DCM)
- Interventions
- Danicamtiv
- Ages
- adults, older adults
- Registry
- NCT07771465
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Frequency and severity of treatment-emergent adverse events (TEAEs)
- Frequency and severity of adverse events of special interest (AESIs)
- Frequency and severity of serious adverse events (SAEs)
- Frequency and severity of disease-related events (DREs)
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered