Purpose of this Study
This is a randomized trial, with some participants receiving the study drug and some receiving placebo. The study drug (an oral pill) will be taken daily for 28 days. The total duration of study activities is 9 weeks.
Who Can Participate?
Eligibility
People can join this study if they are over 50 years old and have a type of heart failure called HFpEF, which means the heart pumps well but does not relax and fill properly. They cannot have other serious heart conditions, such as valve problems, diseases of the heart lining, or weakened heart muscle. They also cannot have had recent heart attacks, blocked heart arteries, abnormal heart rhythms, or major heart surgery. People with certain implanted heart devices are also not able to join this study.
Age Range
50-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This trial is testing the safety and tolerability of a novel drug that targets the fibrosis (hardening or scarring) that occurs in patients with heart failure.
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
DCA09: A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
Principal Investigator
Marat
Fudim
Protocol Number
PRO00119403
NCT ID
NCT07219511
Phase
I
Enrollment Status
Open to Enrollment