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

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

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 can more efficiently decongest ADHF patients in comparison to Control Therapy.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: Reprieve Decongestion Management System; Drug: Diuretic

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Fairhope, Alabama, United States, 36532
      • Eastern Shore Research Institute
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Trinity Health Ann Arbor Hospital
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University
    • St Louis, Missouri, United States, 63130
      • St. Louis VA
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
    • Greensboro, North Carolina, United States, 27401
      • Cone Health
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Research Center at Christ Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29203
      • Prisma Health
  • Texas
    • Austin, Texas, United States, 78705
      • Ascension Texas Cardiovascular
    • Dallas, Texas, United States, 75246
      • Baylor Scott & White
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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.
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.

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 (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.	Drug: Diuretic; 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 Urine Sodium Output	Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.	24 hours post-treatment initiation
Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency.	Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI [≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)], severe electrolyte abnormality (serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq), symptomatic hypotension or hypertensive emergency.	End of treatment, 0-72 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Net Fluid Loss	Difference in the amount of net fluid removed during primary treatment	End of treatment, 0-72 hours
Time on IV Loop Diuretics	Time from initiation of IV loop diuretics to discontinuation of IV loop diuretics	0 hours (treatment initiation) through hospital discharge, up to 1-2 weeks

Collaborators and Investigators

• Sponsor: Reprieve Cardiovascular, Inc
• Investigators: Principal Investigator: James E. Udelson, MD, Division of Cardiology and the CardioVascular Center, Tufts Medical Center

Publications and helpful links

General Publications

• Udelson JE, Javaheri A, Fudim M, Damman K, Biegus J, Afzal A, Amin AN, Bensimhon D, Bischof JJ, Chung ES, Gottlieb RL, Mahler SA, Moreno JD, Ponikowski P, Rao V, Cox Z, Ivey-Miranda J, Collins S, Testani J. Fluid Management of Acute Heart Failure With the Reprieve System: The Randomized Controlled FASTR Trial. JACC Heart Fail. 2026 Apr 28:103062. doi: 10.1016/j.jchf.2026.103062. Online ahead of print.
• Cox ZL, Damman K, Testani JM. Decongestion in heart failure: medical and device therapies. Nat Rev Cardiol. 2025 Dec;22(12):961-977. doi: 10.1038/s41569-025-01152-z. Epub 2025 Apr 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 10, 2025

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Physiological Effects of Drugs; Natriuretic Agents; Pharmacologic Actions; Chemical Actions and Uses; Diuretics
• Other Study ID Numbers: RCV-0006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No