Fluid Management of Acute Heart Failure With the Reprieve System: The Randomized Controlled FASTR Trial.
| Title: | Fluid Management of Acute Heart Failure With the Reprieve System: The Randomized Controlled FASTR Trial. |
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| Authors: | Udelson JE; Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts, USA. Electronic address: Judelson@tuftsmedicalcenter.org.; Javaheri A; Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA; John Cochran VA Hospital, St. Louis, Missouri, USA.; Fudim M; Duke University Medical Center, Division of Cardiology, Duke Clinical Research Institute, Durham, North Carolina, USA.; Damman K; University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.; Biegus J; Department of Cardiology, Clinical Department of Intensive Cardiac Care, Wroclaw Medical University, Faculty of Medicine, Institute of Heart Diseases, Wroclaw, Poland; Jan Mikulicz Radecki University Hospital in Wrocław, Poland.; Afzal A; Texas A&M University College of Medicine and Baylor Scott and White Health, Plano, Texas, USA.; Amin AN; Department of Medicine, Division of Hospital Medicine and Palliative Medicine, University of California, Irvine, California, USA.; Bensimhon D; Cone Health Heart and Vascular Center, Greensboro, North Carolina, USA.; Bischof JJ; Department of Emergency Medicine, The Ohio State University College of Medicine, Columbus, Ohio, USA.; Chung ES; The Lindner Research Center at The Christ Hospital, Cincinnati, Ohio, USA.; Gottlieb RL; Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas, USA; Baylor Scott and White, The Heart Hospital, Dallas, Texas, USA; Baylor Scott and White, The Heart Hospital, Plano, Texas, USA; Department of Internal Medicine, Burnett School of Medicine at TCU, Fort Worth, Texas, USA; Department of Internal Medicine, Texas A&M Health Science Center, Dallas, Texas, USA.; Mahler SA; Departments of Emergency Medicine, Epidemiology and Prevention, and Implementation Science, Wake Forest University School of Medicine, Winston Salem, North Carolina, USA.; Moreno JD; Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.; Ponikowski P; Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.; Rao V; Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.; Cox Z; Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, Tennessee, USA.; Ivey-Miranda J; Hospital de Cardiologia, Instituto Mexicano del Seguro Social, Mexico City, Mexico; Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.; Collins S; Department of Emergency Medicine and Veterans Affairs Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center (GRECC), Nashville, Tennessee, USA; Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Testani J; Department of Internal Medicine, Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut, USA. |
| Source: | JACC. Heart failure [JACC Heart Fail] 2026 Apr 28, pp. 103062. Date of Electronic Publication: 2026 Apr 28. |
| Publication Model: | Ahead of Print |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: United States NLM ID: 101598241 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-1787 (Electronic) Linking ISSN: 22131779 NLM ISO Abbreviation: JACC Heart Fail Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: New York, NY : Elsevier, [2013]- |
| Abstract: | Background: The Reprieve System is designed to overcome barriers limiting safe and rapid decongestion with individualized automated diuretic titration, real-time diuretic response monitoring, and individualized sodium chloride replacement to prevent cardio-renal dysfunction.; Objectives: This study aims to establish proof-of-concept that the Reprieve System can facilitate rapid and safe decongestion.; Methods: FASTR (Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System [DMS]) was a randomized pilot trial comparing the Reprieve System vs a control strategy of optimal diuretic therapy (ODT) in hospitalized patients with acute heart failure. The primary efficacy endpoint was 24-hour natriuresis, and the primary safety endpoint was a composite of dialysis or doubling of creatinine levels, severe electrolyte abnormalities, hypotension, or hypertensive emergency.; Results: A total of 100 patients were enrolled, with 96 receiving randomized treatment (Reprieve, n = 52; ODT, n = 44). At baseline, the median estimated glomerular filtration rate was 49 mL/min/1.73 m2 (Q1-Q3: 36-78 mL/min/1.73 m2) with estimated excess fluid volume of 20 lbs (Q1-Q3: 15-35 lbs). Twenty-four-hour natriuresis was significantly greater with the Reprieve System (1,082 ± 487 mmol) vs ODT (423 ± 290 mmol; P < 0.001). The safety endpoint occurred in 31% of the Reprieve group vs 39% of the ODT group (P = 0.42). Intravenous diuretic therapy duration was shorter with Reprieve [46 hours [Q1-Q3: 29-80 hours]) vs ODT (88 hours [Q1-Q3: 44-143 hours]; P = 0.014). The rate of weight loss (P = 0.002), net fluid loss (P = 0.03), and net natriuresis (P < 0.001) were significantly faster with Reprieve. Change in serum creatinine levels did not differ between the Reprieve (0.19 ± 0.24 mg/dL) and ODT (0.31 ± 0.39 mg/dL; P = 0.07) groups.; Conclusions: In this pilot trial, the Reprieve System safely produced significantly faster decongestion compared with ODT. Confirmation of these findings in the ongoing pivotal trial is required. (Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System [DMS] [FASTR]; NCT05174312).; (Copyright © 2026. Published by Elsevier Inc.) |
| Competing Interests: | Funding Support and Author Disclosures Dr Testani has received grants and/or personal fees from 3ive labs, Bayer, Bristol Myers Squibb, AstraZeneca, Novartis, Cardionomic, MagentaMed, Reprieve Cardiovascular, FIRE1, W.L. Gore, Sanofi, Sequana Medical, Otsuka, Abbott, Merck, Windtree Therapeutics, Lexicon Pharmaceuticals, Precardia, Relypsa, Regeneron, BD, Edwards Lifesciences, Corteria, Terumo, and Lilly; and has a patent for treatment of diuretic resistance issued to Yale and Corvidia Therapeutics Inc, a patent methods for measuring renalase issued to Yale, and a patent Treatment of diuretic resistance pending with Reprieve Cardiovascular. Dr Rao has a patent for treatment of diuretic resistance (US20200079846A1) issued to Yale and Corvidia Therapeutics Inc with royalties paid to Yale University, Dr Rao, and Dr Testani; a patent Methods for measuring renalase (WO2019133665A2) issued to Yale; and has received personal fees from Translational Catalyst. Dr Cox has received grants from AstraZeneca; and personal fees from Abiomed, Vectorious, Kestra Medical Technologies, Reprieve Cardiovascular, WhiteSwell, and Lexicon Pharmaceutical. Dr Ivey-Miranda has received personal fees from AstraZeneca, Boehringer Ingelheim, Novartis, Merck, and Moksha8. Dr Udelson has received consulting fees from and/or clinical trial committee work with Reprieve CV, Cardurion, Alleviant Medical, FIRE1 Foundry, Merck, Bayer, Cytokinetics, Medtronic, MedTrace, Attralus, and Edgewise. Dr Amin was a site Principal Investigator for the FASTR trial; has participated in clinical trial committee work with Reprieve Cardiovascular; and has served as a speaker and/or consultant for Pfizer, Salix, Alexion, AstraZeneca, Bayer, Ferring, Seres, Spero, Eli Lilly, Nova Nordisk, Gilead, Renibus, GlaxoSmithKline, Dexcom, Reprieve Cardiovascular, HeartRite, and AseptiScope. Dr Mahler has received funding/support from Abbott Laboratories, Roche Diagnostics, Quidel, Siemens, Grifols, Pathfast, Beckman Coulter, Genetesis, Reprieve Cardiovascular, National Foundation of Emergency Medicine, BlueJay Diagnostics, Duke Endowment, Brainbox, the Health Resources and Services Administration (1H2ARH399760100), the Emergency Medicine Foundation, and the Agency for Healthcare Research and Quality (R01HS029017 and R21HS029234); is a consultant for Roche, QuidelOrtho, Abbott, Siemens, Genetesis, Pathfast, and Reprieve Cardiovascular; and is the Chief Medical Officer for Impathiq Inc. Dr Gottlieb has served as a consultant to Alnylam Pharmaceuticals, AstraZeneca, Eli Lilly and Company, Johnson and Johnson, and Reprieve Cardiovascular; has received speaking and/or lecture fees from Alnylam Pharmaceuticals and Pfizer; and has received grant support from CareDx. Dr Javaheri has a pending patent for fusion protein nanodiscs for the treatment of heart failure and eye disease; is a member of the scientific advisory board of Mobius Scientific; and has received research funding from AstraZeneca and Bitterroot Bio; and has received research grants from Reprieve and Alleviant. Dr Damman has received speaker and consultancy fees to his employer by Abbott, AstraZeneca, Boehringer Ingelheim, Novartis, Echosens, and FIRE1. Dr Chung has received research funding from Reprieve; has served as a consultant for Medtronic and as a speaker for Boehringer Ingelheim; and is an employee of InterShunt. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. |
| Contributed Indexing: | Keywords: acute heart failure; diuresis; diuretic; heart failure; natriuresis; urine sodium |
| Molecular Sequence: | ClinicalTrials.gov NCT05174312 |
| Entry Date(s): | Date Created: 20260502 Latest Revision: 20260502 |
| Update Code: | 20260503 |
| DOI: | 10.1016/j.jchf.2026.103062 |
| PMID: | 42068320 |
| Database: | MEDLINE |
Journal Article