A Study of the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Condition(s) studied

Investigational drug(s) / intervention(s)

Danicamtiv: Danicamtiv will be administered twice daily for up to 5 years

Study summary

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.

Eligibility

Primary outcome measure(s)

• Frequency and severity of treatment-emergent adverse events (TEAEs) — 61 months
• Frequency and severity of adverse events of special interest (AESIs) — 61 months
• Frequency and severity of serious adverse events (SAEs) — 61 months
• Frequency and severity of disease-related events (DREs) — 61 months
• Frequency of abnormal findings from physical examination — 61 months
• Frequency of abnormal findings from vital signs — 61 months
• Frequency of abnormal findings from 12-lead electrocardiograms (ECGs) — 61 months
• Frequency of abnormal findings from clinical laboratory assessments — 61 months

Trial sites (78)

+ 38 more sites — see the full list on the official registry below.

More Kardigan, Inc. trials in Italy