Danicamtiv for genetic or familial dilated cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial investigates the long-term safety and potential benefits of danicamtiv in adults who have symptomatic genetic or familial dilated cardiomyopathy. Participants will take danicamtiv twice daily for up to five years and undergo about 16 clinical visits with tests to monitor health and response. The study focuses on durability of treatment effects and appropriate chronic dosing over time. Enrollment requires prior participation in a related study and certain safety criteria, with exclusions including recent acute coronary events or recent heart failure hospitalization. Lead sponsor is Kardigan, Inc., with sites at University of Alabama Birmingham, Cedars-Sinai, and UCLA.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama Birmingham
  Birmingham, Alabama, United States Recruiting
• Cedars Sinai
  Los Angeles, California, United States Recruiting
• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Kardigan Clinical Trial Information Team
• Email: clinicaltrials@kardigan.bio
• Phone: 1-877-310-5135

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Danicamtiv for people with symptomatic genetic or familial dilated cardiomyopathy

  This trial will test whether the oral drug danicamtiv can improve heart function and symptoms in adults with symptomatic genetic or familial dilated cardiomyopathy.

  Recruiting at 72 sites Phase 2/3 Kardigan, Inc. · Birmingham, Alabama and 78 other locations · NCT07210723

• Second infusion of FAP-targeted iCDC for end-stage dilated cardiomyopathy

  This study tests whether a second dose of FAP-targeted immunosuppressive CAR-DC therapy can safely improve heart function in adults with end-stage dilated cardiomyopathy who previously had a partial response.

  Recruiting Phase 1 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang / 浙江 · NCT07516288

• AAV Gene Therapy for BAG3-Related Dilated Cardiomyopathy in Adults

  This Phase 1/2 trial tests a single IV dose of AFTX-201 to see if it is safe and potentially helps adults with BAG3-related dilated cardiomyopathy.

  Recruiting at 5 sites Phase 1/2 Affinia Therapeutics · Miami, Florida and 4 other locations · NCT07426419

• Monitoring progression of chronic cardiovascular conditions

  This project will collect wearable physiologic data from adults with cardiovascular conditions to see how their heart disease changes over time.

  Recruiting Prolaio · Chicago, Illinois · NCT07420907

• Multimodal analysis of heart biopsy samples

  This project will take one extra small heart biopsy during a clinically needed procedure to test whether detailed molecular and immune analyses can find disease-specific signatures in adults with cardiomyopathies, myocarditis, cardiac amyloidosis, or after heart transplant.

  Recruiting University Hospital, Essen · Essen, North Rhine-Westphalia · NCT07359690

• T1 mapping to characterize heart tissue in common heart diseases

  This project tests whether T1 mapping MRI scans, including dye-free native T1, can define normal and disease-specific heart tissue values for adults with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing, Beijing Municipality · NCT07354646

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.