332 Participants NeededMy employer runs this trial

Danicamtiv for Dilated Cardiomyopathy

(KINSHIP-OLE Trial)

Recruiting at 77 trial locations
KC
Overseen ByKardigan Clinical Trial Information Team
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Kardigan, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults who have symptoms of genetic or inherited dilated cardiomyopathy (DCM). Participants should not have other serious health conditions that could interfere with the study.

Inclusion Criteria

Completed 24 weeks of blinded study treatment and planned assessments in Part 1 or Part 2 of the DAN-301 study
I use effective birth control during and after the study if I am sexually active.
I can understand the study, its risks, and give written consent to participate.

Exclusion Criteria

I do not have another cancer needing treatment that could shorten my life.
I have not had a stroke or heart event in the past 90 days.
I have not had a recent serious heart problem or heart procedure in the last 90 days.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take the investigational medicine, danicamtiv, twice daily throughout the study

Up to 5 years
16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive danicamtiv to assess long-term safety and efficacy

Up to 5 years

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing danicamtiv, an experimental medication, to see how safe and effective it is for treating people with genetic or familial DCM over a long period.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DanicamtivExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kardigan, Inc.

Lead Sponsor

Trials
1
Recruited
700+