Purpose of this Study
We are doing this study to evaluate an experimental technology called the Reprieve Decongestion Management System (the study device) for heart failure patients with fluid overload. The study device is designed to help people with heart failure feel better by removing extra fluid from their body quickly.
The device is programmed to deliver an appropriate amount of medication at the right time to help people shed extra fluid through urination. We want to know if this device works better than the standard treatment. The standard treatment is to prescribe diuretics (medication to increase urination) at a specified dose and dosage schedule.
Who Can Participate?
Eligibility
Adults ages 22+ who:
- Are diagnosed with heart failure
- Are admitted to the hospital and at least 10 pounds above their normal weight and the excess weight is due to fluid (water) retention
- Are not resistant to diuretic medications
- Do not have severely reduced kidney function
Age Range
22-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to either:
- Use the study device for up to 72 hours; OR
- Receive the standard treatment of diuretic therapy
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve System II
Principal Investigator
Marat
Fudim
Protocol Number
PRO00117989
NCT ID
NCT06898515
Phase
III
Enrollment Status
Pending Open to Enrollment