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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 is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.
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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. |
|
| Optimal Diuretic Therapy | Active Comparator | 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. |
|
| 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 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:
| Through study completion, an average of 90 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Netherlands | ||||
| Wroclaw Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40295876 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Apr 11, 2024 |
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|
| Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) | Drug | Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC). |
|
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 |
| Wroclaw |
| Poland |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D004232 | Diuretics |
| D005665 | Furosemide |
| D002034 | Bumetanide |
| D000077786 | Torsemide |
| D006852 | Hydrochlorothiazide |
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
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