Reprieve System for Heart Failure

(FASTR-II Trial)

Recruiting at 55 trial locations

Overseen By Annemarie Forrest

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Reprieve Cardiovascular, Inc

Must be taking: Loop diuretics

Disqualifiers: Urologic issues, Hemodynamic instability, Uncontrolled arrhythmias, Severe lung disease, Acute infection, eGFR <25, Recent MI, Severe electrolyte abnormalities, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 72 hours

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Reprieve System for individuals with acute decompensated heart failure (ADHF), a condition where the heart fails to pump enough blood, leading to sudden symptoms like swelling and difficulty breathing. Researchers aim to determine if the Reprieve System can remove excess fluid more effectively than standard diuretic therapy, which helps the body eliminate excess water and salt. Participants will either receive the Reprieve System or follow the standard treatment to compare outcomes. This trial may suit those with heart failure who take daily diuretics and experience significant discomfort or limitations in daily activities due to excess fluid. As a Phase 3 trial, this treatment is in the final stage before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must have a current prescription for a daily loop diuretic, it seems you may need to continue that medication.

What prior data suggests that the Reprieve System is safe for treating acute decompensated heart failure?

Research has shown that the Reprieve System is safe for treating sudden worsening of heart failure. Studies have found that this device effectively removes extra fluid and salt without increasing the risk of kidney damage. No increases in serious issues, such as kidney problems or severe imbalances in body salts, were reported—common concerns with similar treatments. This suggests that the Reprieve System is well-tolerated and does not pose additional safety risks compared to standard treatments. ^{1 2 3 4 5}

Why do researchers think the Reprieve System might be promising for heart failure?

The Reprieve System is unique because it offers a personalized and optimized approach to managing heart failure. Unlike standard diuretic therapies, which follow general guidelines, this system uses a study device to tailor diuretic and saline infusions specifically for each patient. Researchers are excited about this treatment because it promises to enhance the precision of heart failure management, potentially improving patient outcomes by ensuring each individual receives exactly what their body needs.

What evidence suggests that the Reprieve System is effective for acute decompensated heart failure?

Research has shown that the Reprieve System, which participants in this trial may receive, effectively removes excess fluid and salt from patients with acute decompensated heart failure (ADHF). In earlier studies, this system safely removed fluid and reduced the risk of kidney damage, a common concern with standard treatments. Patients using the Reprieve System exhibited high levels of salt in their urine, indicating that the system effectively relieves body congestion. This suggests the system might manage fluid levels in ADHF patients more effectively than traditional water pills. ^{1 2 3 4 6}

Who Is on the Research Team?

Javed Butler, MD, MPH, MBA

Principal Investigator

Baylor Scott and White Health

Are You a Good Fit for This Trial?

This trial is for adults over 22 with acute decompensated heart failure who are significantly above their dry weight, showing new or worsening symptoms, and at risk of diuretic resistance. It's not for those with severe kidney issues, electrolyte imbalances that can't be corrected, life expectancy under 6 months, certain infections or cardiovascular conditions, uncontrolled arrhythmias, severe lung disease requiring oxygen therapy, or women who are pregnant/breastfeeding.

Inclusion Criteria

I am more than 10 pounds over my healthy weight.

I have heart failure, worsening symptoms, and will be hospitalized for more than a day.

I am 22 or older and can follow the study's procedures.

Exclusion Criteria

My kidney function is very low or I am on dialysis.

Severe electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial

Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Reprieve System therapy or Optimal Diuretic Therapy (ODT) for decongestion

Up to 72 hours

In-hospital treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CV mortality and HF rehospitalizations

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Furosemide
• Reprieve System

Trial Overview The FASTR-II study tests if the Reprieve System can better remove excess fluid from patients with acute decompensated heart failure compared to standard optimal diuretic therapy using furosemide infusion. The goal is to see which method more effectively reduces congestion in these patients.

How Is the Trial Designed?

Group I: Reprieve System Experimental Treatment 1 Intervention

Participants 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 (ODT) Active Control 1 Intervention

Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Group III: Registry Active Control 1 Intervention

Participants will be treated per local site usual care.

Who Is Running the Clinical Trial?

Reprieve Cardiovascular, Inc

Lead Sponsor

Trials

5

Recruited

590+

Citations

1. reprievecardio.com reprievecardio.com/news-post/reprieve-cardiovascular-builds-clinical-momentum-with-positive-results-from-fastr-pilot-trial-and-fda-investigational-device-exemption-approval-for-pivotal-trial

Reprieve Cardiovascular Builds Clinical Momentum with ... The trial demonstrated the Reprieve System's ability to safely and precisely remove fluid and sodium, reducing the risks of kidney injury often seen with ...

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

Reprieve System for the Treatment of Patients With Acute ... The Reprieve System (Reprieve Cardiovascular, Milford, MA) is a bedside fluid-management device to treat ADHF and is composed of 3 innovations that could ...

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

Reprieve System Safely Aids Decongestion in Acute HF Mean IV saline replacement in the Reprieve group was 3.3 L per 24 hours. The primary efficacy outcome was 24-hour urine sodium output, and this ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06898515

Study Details | NCT06898515 | Fluid Management of Acute ... The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the ...

5. 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 ...

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

Device-based therapy for decompensated heart failure In an ongoing clinical trial of CPNS (NCT04814134), initial results (29) in 7 patients showed no adverse events. CPNS therapy increased heart contractility (LV ...