Purpose of this Study
Participants will receive the study drug injected into an artery within the heart during a procedure in the clinic. They will be followed with visits during the first year, and there is a long term follow up period of 4 years.
Who Can Participate?
Eligibility
Those with chronic ischemic or non-ischemic cardiomyopathy and a diagnosis of Class III/IV heart failure and presence of a cardioverter defibrillator (ICD) is required. Participants must be able to walk a minimum of 50 meters.
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
To study the safety and tolerability of a one-time intracoronary administration of the study drug.
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DCA07: A Phase 1b/2 Trial of the Safety and Efficacy of SRD-001 (AAV1/SERCA2a) in Subjects with Heart Failure with Reduced Ejection Fraction
Principal Investigator
Marat
Fudim
Protocol Number
PRO00116776
NCT ID
NCT04703842
Phase
I/II
Enrollment Status
Open to Enrollment