Reprieve System for Heart Failure
(FASTR-II Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byJaved Butler, MD, MPH, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Reprieve Cardiovascular, Inc

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

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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

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Treatment Details

Interventions

Furosemide (Diuretic)
Reprieve System (Device)

Trial OverviewThe 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

3Treatment groups

Experimental Treatment

Active Control

Group I: Reprieve SystemExperimental Treatment1 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 Control1 Intervention

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

Group III: RegistryActive Control1 Intervention

Participants will be treated per local site usual care.