FASTR II Trial (Acute Decompensated Heart Failure) - Clinical Trial
What is the 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.
Worsening Heart Failure Accompanied by Fluid Overload
Who Can Participate in the Study?
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
For more information, contact the study team at kimberly.biever@dm.duke.edu.
What is Involved?
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
After you are discharged and return home, we will schedule you to come in for return visits about 1 weeks and 4 weeks later. We will also call you on the phone to check in about 3 months and 6 months after your discharge.
Study Details
