Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
This study is looking at a new way to treat acute decompensated heart failure, a condition where your heart can't pump enough blood, leading to fluid build-up. Researchers are comparing a new device called the Reprieve System with the usual treatment of furosemide infusions. The main goal is to see if the Reprieve System is more effective at helping your body get rid of excess fluid when you're in the hospital with a heart failure flare-up. This is a Phase 3 study, meaning it's a key stage before a new treatment might become widely available. The study is for adults over 22 who are in the hospital with worsening heart failure and have a high chance of not responding well to standard diuretic treatment alone.
At a glance
What is this study about?
When your heart isn't working as well as it should, fluid can build up in your body, leading to symptoms like shortness of breath and swelling. This is known as heart failure. If these symptoms suddenly get much worse, it's called acute decompensated heart failure, and it often means a hospital stay. Doctors usually give medicines called diuretics, like furosemide, to help your body get rid of this extra fluid.
This study is investigating a new treatment called the Reprieve System. It's designed to help manage the fluid build-up more effectively than standard diuretic treatment alone. The researchers want to find out if the Reprieve System can help patients get rid of extra fluid more quickly and efficiently when they are in the hospital for heart failure.
This is a 'Phase 3' study, which means it's a large and important step. If this study shows the Reprieve System is safe and effective, it could become a new option for people struggling with acute decompensated heart failure in the future. The project aims to improve how doctors manage fluid in patients during these crucial hospital stays.
Key takeaways
- The study tests a new device (Reprieve System) for severe heart failure.
- It compares the new system with standard fluid management using water pills.
- The goal is to remove extra fluid more efficiently during hospital stays.
- It's for adults (22+) admitted with worsening heart failure symptoms.
- Participation involves close monitoring during your hospital admission.
Who may be eligible?
To join this study, you need to be at least 22 years old and currently in the hospital because your heart failure symptoms have gotten worse. You should also have signs of fluid build-up that need treatment and be expected to stay in the hospital for more than 24 hours. A key requirement is that your healthcare team believes you have a good amount of extra fluid (at least 10 pounds or 4.5 kg more than your usual dry weight) and you regularly take a type of water pill (loop diuretic) for your heart failure.
Another important factor for joining is that you show signs of potentially having 'diuretic resistance'. This means your body might not respond as well to standard water pills as it should. This could be indicated by things like low chloride levels in your blood, making less than a litre of urine in six hours after a strong water pill, or low sodium levels in your urine after taking a water pill.
However, you can't join if you have serious kidney problems or are already on kidney dialysis. Other reasons you might not be able to participate include having very low blood pressure, needing IV medicines to support your blood pressure, a very fast and uncontrolled heart rate, severe lung disease requiring a lot of oxygen at home, or an active infection. Issues with urinary catheters or certain other serious heart conditions would also prevent you from joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 22 or older?
- Are you currently in the hospital for worsening heart failure?
- Do you have a lot of extra fluid retention (about 10 lbs/4.5 kg)?
- Do you usually take water pills (loop diuretics) for your heart failure?
- Has your doctor suggested your body might not be responding well to water pills?
- Do you *not* have severe kidney disease or very low blood pressure?
What does participation involve?
If you decide to take part in this study, you will either receive treatment with the Reprieve System or continue with the usual optimal diuretic therapy. Both treatments aim to help your body get rid of excess fluid. Your doctors will carefully monitor your condition, including your fluid levels, blood tests, and overall heart health throughout your hospital stay. They will be checking how well each treatment works to reduce fluid build-up. You will have regular assessments as part of your care, and your progress will be closely followed by the study team. The total duration of your participation will depend on how long you need hospital treatment for your acute heart failure, typically during your admission.
Potential risks and benefits
Locations (53)
- University of California IrvineVerified postcodeIrvine, United States· Recruiting
- Scripps Memorial HospitalVerified postcodeLa Jolla, United States· Not yet recruiting
- UC Davis Medical CenterVerified postcodeSacramento, United States· Recruiting
- University of FloridaVerified postcodeGainesville, United States· Recruiting
- Piedmont Atlanta HospitalVerified postcodeAtlanta, United States· Recruiting
- Piedmont Augusta HospitalVerified postcodeAugusta, United States· Recruiting
- Northeast Georgia Medical CenterVerified postcodeGainesville, United States· Recruiting
- Advocate Christ Medical CenterVerified postcodeOak Lawn, United States· Not yet recruiting
- University of Kansas Medical CenterVerified postcodeKansas City, United States· Recruiting
- University of Louisville HospitalVerified postcodeLouisville, United States· Not yet recruiting
- Trinity Health Ann Arbor HospitalVerified postcodeAnn Arbor, United States· Recruiting
- Corewell Health Butterworth HospitalVerified postcodeGrand Rapids, United States· Recruiting
Common questions
What is 'acute decompensated heart failure'?
It means your long-term heart failure symptoms, like shortness of breath or swelling, have suddenly gotten much worse, often requiring a hospital stay.
What is the Reprieve System?
It's a new device being tested to help your body remove extra fluid more effectively than standard water pills alone.
What are 'diuretics'?
These are commonly called 'water pills'. They are medicines that help your body get rid of excess salt and water through your urine.
How to find out more
Annemarie Forrest
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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