Fluid Management Systems for Heart Failure
(FASTR Trial)

Recruiting at 8 trial locations

Overseen ByAnnemarie 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 GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial compares the Reprieve DMS system, a device that removes excess fluid, to usual treatment in patients with acute decompensated heart failure. The goal is to see if the device can more effectively reduce fluid buildup and improve symptoms. Newer devices make it feasible in most hospitals.

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.

Is the Reprieve Decongestion Management System safe for use in humans?

The TARGET-1 and TARGET-2 studies suggest that the Reprieve System, which helps manage fluid balance in heart failure, is safe when used alongside standard treatments.¹ ² ³ ⁴ ⁵

How does the Reprieve Decongestion Management System treatment differ from other treatments for heart failure?

The Reprieve Decongestion Management System is unique because it continuously monitors urine output and adjusts hydration fluid to maintain a set fluid balance, unlike traditional diuretics that only remove excess fluid. This system aims to improve decongestion in acute heart failure by providing a more controlled and precise fluid management approach.¹ ³ ⁴ ⁵ ⁶

Eligibility Criteria

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.

See 10 more

Timeline

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

Treatment Details

Interventions

Diuretic
Reprieve Decongestion Management System

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Reprieve Decongestion Management SystemExperimental Treatment1 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 TherapyActive Control1 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.