A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy (NCT07210723)
A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy
🩺 Plain-English Summary (8th-Grade Level)
The Sponsor is studying an investigational medication called danicamtiv to determine if it can help people with genetic and familial dilated cardiomyopathy (DCM). Investigational means that the safety and effectiveness of danicamtiv have not been established. Currently, there are no approved drugs that are designed specifically to treat genetic or familial DCM. The purpose of this study is to evaluate how well danicamtiv works compared to a placebo (sugar pill that looks like danicamtiv pill but does not contain any danicamtiv) and see how safe it is for people with genetic and familial DCM. In DCM, the heart muscle weakens and enlarges, making it harder for the heart to pump blood; this can happen for different reasons. Some people have DCM because of a change in a gene (called genetic DCM). Others may have DCM that runs in their family, even if no specific gene change is found (called familial DCM). The main goals of the study are: * To assess the effect of danicamtiv on cardiac function using echocardiogram. * To evaluate the impact of danicamtiv on exercise capacity * To evaluate the safety and tolerability of danicamtiv Participants will: * Take danicamtiv or placebo every day for approximately 6 months * Visit the clinic about 12 times for initial evaluation, checkups, tests and follow up
Who can join: Review the eligibility criteria below.
Location: University of Alabama Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (78 Sites)
Showing the first 25 of 78 sites.
- University of Alabama Birmingham — Birmingham, Alabama
- Cedars Sinai — Los Angeles, California
- University of California, Los Angeles (UCLA) - David Geffen School of Medicine — Los Angeles, California
- University of California, San Diego (UCSD) - Medical Center — San Diego, California
- UCSF — San Francisco, California
- Stanford University Medical Center — Stanford, California
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Mayo Clinic - Jacksonville — Jacksonville, Florida
- Northwestern University — Chicago, Illinois
- Louisiana State University (LSU) Health Sciences Center — New Orleans, Louisiana
- Johns Hopkins Medicine — Baltimore, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Henry Ford Health System — Detroit, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Mayo Clinic Rochester — Rochester, Minnesota
- Saint Luke's Mid America Heart Institute — Kansas City, Missouri
- Washington University in St. Louis — St Louis, Missouri
- University of Nebraska Medical Center — Omaha, Nebraska
- NYU Langone Health — New York, New York
- Columbia University Medical Center/ New York Presbyterian Hospital — New York, New York
- Duke University Medical Center — Durham, North Carolina
- The Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio
- Oregon Health & Science University (OHSU) — Portland, Oregon
- University of Pennsylvania — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (877) 310-5135
Email: clinicaltrials@kardigan.bio
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Symptomatic Genetic Dilated Cardiomyopathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.