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

RecruitingPhase 3Ages 18 Years - anyAllKardigan, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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. Exclusion Criteria: 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.
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What it tests

  • Danicamtiv
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Where

78 sites
University of Alabama Birmingham
Birmingham, United States
Cedars Sinai
Los Angeles, United States
University of California, Los Angeles (UCLA) - David Geffen School of Medicine
Los Angeles, United States
University of California, San Diego (UCSD) - Medical Center
San Diego, United States
University of California, San Francisco (UCSF)
San Francisco, United States
Stanford University Medical Center
Stanford, United States
MedStar Washington Hospital Center
Washington D.C., United States
Mayo Clinic - Jacksonville
Jacksonville, United States

โ€ฆand 70 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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