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

ConditionSymptomatic Genetic Dilated Cardiomyopathy (DCM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKardigan, Inc.

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Other recent (<90 days) cardiovascular events (e.g., cerebrovascular accident).

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Danicamtiv

    Drug

    Danicamtiv will be administered twice daily for up to 5 years

Treatment groups

332 Participants
are divided into 1 treatment group
Group A: DanicamtivExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency and severity of treatment-emergent adverse events (TEAEs)

Time frame
61 months
2

Frequency and severity of adverse events of special interest (AESIs)

Time frame
61 months
3

Frequency and severity of serious adverse events (SAEs)

Time frame
61 months
4

Frequency and severity of disease-related events (DREs)

Time frame
61 months

Secondary outcomes

1

Change from Baseline (Day 1) to Week 26, Months 18, 30, 42, 54, 60, and 61 in cardiac structure, function, and size using Transthoracic Echocardiogram (TTE)

Including but not limited to left atrial function index (LAFI), left atrial volume index (LAVI), maximum left atrial volume index (LAmaxVi), minimum left atrial volume index (LAminVi), left atrial emptying fraction (LAEF), left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDD), left ventricular end diastolic volume (LVEDV), left ventricular end systolic volume (LVESV), early diastolic mitral inflow velocity/early diastolic mitral annular tissue velocity (E/e'), left ventricular global longitudinal strain (LVGLS), left ventricular global circumferential strain (LVGCS), and left ventricular mass index (LVMI)

Time frame
61 months
2

Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS)

All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.

Time frame
61 months
3

Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Utility Score

Time frame
61 months
4

Change from Baseline (Day 1) to Week 26, Months 12, 18, 24, 30, 36, 42, 48, 54, 60, and 61 in EuroQol Visual Analogue Scale (EQ-VAS) Score

Time frame
61 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kardigan, Inc.

Lead sponsor

Source ClinicalTrials.gov
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