EU Sites: Fluid Management of Acute Decompensated Heart Failure With Reprieve Decongestion Management System (FASTR-EU) (FASTR-EU)

EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)

The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS 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 DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: Reprieve Decongestion Management System; Drug: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tony Fields; Phone Number: 650-224-3884; Email: tfields@reprievecardio.com

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
    • Contact: Kevin Damman, MD
• Poland
  • Wrocław, Poland
    • Wroclaw Medical University
    • Contact: Jan Biegus, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
2. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
3. Prior use of loop diuretics within 30 says prior to admission.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter.
2. Hemodynamic instability.
3. Dyspnea due primarily to non-cardiac causes.
4. Acute infection with evidence of systemic involvement.
5. Inability to follow instructions or comply with follow-up procedures.
6. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
7. Severe electrolyte abnormalities.
8. Presence of active coronavirus disease 2019 (COVID-19) infection.
9. Enrollment in another interventional trial during the index hospitalization.
10. Inability of the patient to stand and obtain daily standing weights.
11. Inability to return for follow-up study visits.
12. Life expectancy less than 3 months.
13. Women who are pregnant or intend to become pregnant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reprieve Decongestion Management System; Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.	Device: Reprieve Decongestion Management System; The Reprieve Decongestion Management System, or Reprieve DMS, is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
Active Comparator: Optimal Diuretic Therapy; Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials [Diuretic Strategies in Patients with Acute Heart Failure Trail (DOSE), Acetazolamide in Decompensated Heart Failure with Volume Overload Trial (ADVOR), and Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure Trial (CLOROTIC)] for patients randomized to control arm of the trial.	Drug: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide); Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sodium loss (in mmol of sodium) per 24 hours	Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).	End of treatment, an average of 72 hours
Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.	Primary safety endpoint is positive if any of the following occurs in an individual participant: Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) [≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)]; Severe electrolyte abnormality defined as serum potassium <3.0 milliequivalent/liter (mEq/L), magnesium <1.3 mEq/L, or sodium <135 mEq; Symptomatic hypotension (systolic pressure <80mmHg) or hypertensive (systolic pressure >200 mmHg and/or diastolic pressure >120 mmHg) emergency.	Through study completion, an average of 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours	Difference between volume of urine output and fluid input during primary treatment normalized to 24 hours.	End of treatment, an average of 72 hours
Weight loss per 24 hours at end of randomized therapy	Total time on loop diuretics during primary treatment	End of treatment, an average of 72 hours
Time on IV loop diuretic	Total time on loop diuretics from initiation of randomized therapy to last dose of IV loop diuretic administered for ADHF	End of treatment, an average of 72 hours
Number of participants with ≥ 0.3 mg/dL increase in serum creatinine	In hospital worsening renal function defined as ≥ 0.3 mg/dL increase in serum creatinine during randomized therapy.	End of treatment, an average of 72 hours

Collaborators and Investigators

• Sponsor: Reprieve Cardiovascular, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): April 9, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Membrane Transport Modulators; Anticonvulsants; Sodium Chloride Symporter Inhibitors; Sodium Potassium Chloride Symporter Inhibitors; Acetazolamide; Hydrochlorothiazide; Furosemide; Diuretics; Bumetanide; Torsemide
• Other Study ID Numbers: RCV-0006-EU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes