Fluid Management Systems for Heart Failure

(FASTR Trial)

No longer recruiting at 20 trial locations

Overseen By Annemarie Forrest

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Reprieve Cardiovascular, Inc

Must be taking: Loop diuretics

Disqualifiers: Renal failure, Severe heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called Reprieve DMS (Decongestion Management System) to determine if it can help people with sudden worsening of heart failure feel better faster than the usual medication approach. It compares this system to the best current treatments using diuretics, which help the body eliminate excess fluid. The trial seeks participants who are hospitalized with heart failure, carry extra weight due to fluid buildup, and have used diuretics in the past month. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance heart failure management.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves comparing different therapies for heart failure, it's possible that some medication adjustments might be needed. Please consult with the study team for specific guidance.

What prior data suggests that the Reprieve Decongestion Management System is safe for heart failure patients?

Research has shown that the Reprieve Decongestion Management System (DMS) is safe for people with heart failure. In earlier studies, the system increased sodium and urine output, supported weight loss, and did not harm the kidneys. These positive signs indicate that the system can remove extra fluid without causing new issues. The system is designed to enhance the effectiveness of diuretics, which help the body eliminate excess fluid. This is crucial for people with heart failure, who often retain too much fluid. Overall, the Reprieve DMS appears to be well-tolerated, allowing use with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage fluid levels in patients with heart failure, potentially improving outcomes over standard diuretic treatments. The Reprieve Decongestion Management System is unique as it offers a personalized and optimized approach, combining diuretic and saline infusion tailored to each patient using a specialized device. This system could provide more precise control over fluid management, which is crucial for heart failure patients, potentially enhancing their quality of life and reducing hospitalizations.

What evidence suggests that the Reprieve Decongestion Management System is effective for heart failure?

Studies have shown that the Reprieve Decongestion Management System, a treatment tested in this trial, can aid patients with sudden heart failure worsening by enhancing the body's ability to remove excess fluid. Research indicates that the Reprieve System improves salt and water removal and promotes weight loss, crucial for reducing fluid buildup. Notably, these benefits occur without harming the kidneys, a common concern with other treatments. Early findings suggest that this system may outperform traditional water pills, or diuretics, used in the trial's other arm as Optimal Diuretic Therapy, in alleviating fluid buildup in heart failure patients. Overall, evidence supports the Reprieve System as a promising option for managing fluid levels in these patients. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for hospitalized patients with acute decompensated heart failure who have symptoms and signs of the condition, are significantly above their dry weight, and have been on loop diuretics. It's not suitable for those with unstable vital signs, non-heart-related breathing issues, severe infections or electrolyte problems, active COVID-19, other serious health conditions including substance abuse or mental disorders that affect study compliance.

Inclusion Criteria

I am at least 10 pounds heavier than my usual weight.

I am hospitalized with heart failure, having both symptoms and signs.

I have used water pills within the last 30 days.

Exclusion Criteria

Severe electrolyte abnormalities

Life expectancy less than 3 months

I cannot stand up to weigh myself daily.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive decongestive therapy using either the Reprieve DMS system or Optimal Diuretic Therapy

72 hours

Daily monitoring during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Diuretic
• Reprieve Decongestion Management System

Trial Overview The study compares a new therapy using the Reprieve Decongestion Management System to standard Optimal Diuretic Therapy in treating acute decompensated heart failure. The goal is to see if the Reprieve system can better remove excess fluid from patients compared to conventional diuretic treatment.

How Is the Trial Designed?

Group I: Reprieve Decongestion Management System Experimental Treatment 1 Intervention

Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.

Group II: Optimal Diuretic Therapy Active Control 1 Intervention

Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.

Who Is Running the Clinical Trial?

Reprieve Cardiovascular, Inc

Lead Sponsor

Trials

5

Recruited

590+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ejhf.1533

Controlled decongestion by Reprieve therapy in acute ... Serial assessment of spot urine sodium predicts effectiveness of decongestion and outcome in patients with acute heart failure. Eur J Heart Fail ...

2. reprievecardio.com reprievecardio.com/news-post/reprieve-cardiovascular-completes-enrollment-in-randomized-pilot-trial-evaluating-first-of-its-kind-personalized-fluid-management-system-for-acute-decompensated-heart-failure

Reprieve Cardiovascular Completes Enrollment in ... The FASTR trial aims to compare the effectiveness of decongestive therapy administered by the Reprieve System with Optimal Diuretic Therapy (ODT) in patients ...

3. tctmd.com tctmd.com/news/reprieve-system-safely-aids-decongestion-acute-hf-fastr-pilot-rct

Reprieve System Safely Aids Decongestion in Acute HF Use of the system led to improvements in sodium output, urine output, and weight loss, while preserving kidney function, compared with a ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916425000533

Reprieve System for the Treatment of Patients With Acute ... Novel devices optimizing existing diuretic therapies could address this unmet need and improve decongestion with minimal risk, resource use and incremental cost ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06898515

Study Details | NCT06898515 | Fluid Management of Acute ... The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control Therapy. Official Title. Fluid ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9532699/

Device-based therapy for decompensated heart failure The Reprieve System™ (Reprieve Cardiovascular, Milford, MA, USA) is another new decongestion device for improving outcomes for patients with ADHF. The goal ...