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

NCT ID: NCT06362668

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2024-10-31

Brief Summary

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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reprieve Decongestion Management System

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide)

Intervention Type: DRUG

Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: DRUG

Eligibility Criteria

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.

4. ≥ 18 years of age able to provide informed consent and comply with study procedures.

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. Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.

6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.

7. Inability to follow instructions or comply with follow-up procedures.

8. 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.

9. Severe electrolyte abnormalities.

10. Presence of active coronavirus disease 2019 (COVID-19) infection.

11. Enrollment in another interventional trial during the index hospitalization.

12. Inability to return for follow-up study visits.

13. Life expectancy less than 3 months.

14. Women who are pregnant or intend to become pregnant.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reprieve Cardiovascular, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Wroclaw Medical University

Wroclaw, , Poland

Countries

Netherlands; Poland

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RCV-0006-EU

Identifier Type: -

Identifier Source: org_study_id