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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reprieve Decongestion Management System | Experimental | Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment. |
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| Optimal Diuretic Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reprieve Decongestion Management System | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E. Udelson, MD | Division of Cardiology and the CardioVascular Center, Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Shore Research Institute | Fairhope | Alabama | 36532 | United States | ||
| University of California Irvine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42068320 | Derived | 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. | |
| 40295876 |
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2,216 patients were screened between July 2022 and October 2024 at 16 hospitals in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Optimal Diuretic Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2023 |
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| Diuretic | Drug | Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC). |
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| 0 hours (treatment initiation) through hospital discharge, up to 1-2 weeks |
| Irvine |
| California |
| 92697 |
| United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Trinity Health Ann Arbor Hospital | Ypsilanti | Michigan | 48197 | United States |
| St. Louis VA | St Louis | Missouri | 63130 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| Cone Health | Greensboro | North Carolina | 27401 | United States |
| Atrium Health Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| The Lindner Research Center at Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Ohio State University Hospital | Columbus | Ohio | 43210 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Prisma Health | Columbia | South Carolina | 29203 | United States |
| Ascension Texas Cardiovascular | Austin | Texas | 78705 | United States |
| Baylor Scott & White | Dallas | Texas | 75246 | United States |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | United States |
| Derived |
| 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. |
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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Serum creatinine | Mean | Standard Deviation | mg/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Total Urine Sodium Output | Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation. | Posted | Mean | Standard Deviation | mmol of sodium | 24 hours post-treatment initiation |
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| Primary | 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. | Posted | Number | total number of events | End of treatment, 0-72 hours. |
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| Secondary | Net Fluid Loss | Difference in the amount of net fluid removed during primary treatment | Posted | Mean | Standard Deviation | liters | End of treatment, 0-72 hours |
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| Secondary | Time on IV Loop Diuretics | Time from initiation of IV loop diuretics to discontinuation of IV loop diuretics | Posted | Median | Inter-Quartile Range | hours | 0 hours (treatment initiation) through hospital discharge, up to 1-2 weeks |
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From enrollment until end of follow up, up to 90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 3 | 52 | 29 | 52 | 44 | 52 |
| EG001 | 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. | 3 | 44 | 23 | 44 | 35 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cardiac disorder | Cardiac disorders | Non-systematic Assessment |
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| Administration site disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Infectious disorders | Infections and infestations | Non-systematic Assessment |
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| Falls and limb injury disorders | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Neoplasm disorders | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
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| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment |
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| Renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment |
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| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Vascular disorders | Vascular disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Electrolyte and fluid disorders | General disorders | Non-systematic Assessment | Treatment-related |
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| Cardiac disorder | Cardiac disorders | Non-systematic Assessment | Treatment-related |
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| Administration site disorders | General disorders | Non-systematic Assessment | Treatment-related |
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| Falls and limb injury disorders | Injury, poisoning and procedural complications | Non-systematic Assessment | Treatment-related |
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| Renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment | Treatment-related |
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| Psychiatric disorders | Psychiatric disorders | Non-systematic Assessment | Treatment-related |
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| Vascular disorder | Vascular disorders | Non-systematic Assessment | Treatment-related |
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| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Treatment-related |
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| Other disorders | General disorders | Non-systematic Assessment | Treatment-related |
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| Catheter-associated UTI | Infections and infestations | Non-systematic Assessment | Treatment-related |
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| Cardiac disorder | Cardiac disorders | Non-systematic Assessment | Device-related |
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| Electrolyte disorder | General disorders | Non-systematic Assessment | Device-related |
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| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Device-related |
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| Renal and urinary disorders | Renal and urinary disorders | Non-systematic Assessment | Device-related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annemarie Forrest | Reprieve Cardiovascular | (617) 848-0400 | aforrest@reprievecardio.com |
| May 4, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Male |
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| Black |
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| Other |
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