Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of Danicamtiv in Adults With Symptomatic Genetic and Familial Dilated Cardiomyopathy

Details

The Sponsor is studying an investigational medication called danicamtiv to understand its long-term benefits and risks in patients with symptomatic genetic or familial DCM. This study will examine the durability of treatment effects with continued exposure and evaluate appropriateness of chronic dosing over time.

Participants will:

  • Take the investigational medicine, danicamtiv, twice daily throughout the study, which is up to 5 years
  • Visit the clinic about 16 times for clinical evaluations and diagnostic tests

Keywords

Symptomatic Genetic Dilated Cardiomyopathy (DCM), Danicamtiv

Eligibility

You can join if…

Open to people ages 18 years and up

  1. 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.
  2. If sexually active, must use a highly effective birth control method from the Screening Visit through 3 months after the last dose.
  3. 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.

You CAN'T join if...

  1. 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.
  2. Recent (<90 days) hospitalization for heart failure (HF) or use of IV diuretic.
  3. Other recent (<90 days) cardiovascular events (e.g., cerebrovascular accident).
  4. 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.
  5. Any malignancy requiring treatment after enrollment in DAN-301 that could limit patient's survival.

Locations

  • University of California, Los Angeles (UCLA) - David Geffen School of Medicine
    Los Angeles California 90095 United States
  • Cedars Sinai
    Los Angeles California 90048 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Kardigan, Inc.
ID
NCT07771465
Phase
Phase 3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 332 study participants
Last Updated