Reprieve System for Heart Failure

(FASTR-II Trial)

Recruiting at 10 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

Trial Summary

What is the purpose of this trial?

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve System to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve System can more efficiently decongest ADHF patients in comparison to Control 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.

Research Team

Javed Butler, MD, MPH, MBA

Principal Investigator

Baylor Scott and White Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+