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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: Reprieve Decongestion Management System
* Drug: Diuretic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign. ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider. Prior use of loop diuretics within 30 says prior to admission. Exclusion Criteria: Inability to place Foley catheter or IV catheter. Hemodynamic instability. Dyspnea due primarily to non-cardiac causes. Acute infection with evidence of systemic involvement. Inability to follow instructions or comply with follow-up procedures. 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. Severe electrolyte abnormalities. Presence of active COVID-19 infection. Enrollment in another interventional trial during the index hospitalization. Inability of the patient to stand and obtain daily standing weights. Inability to return for follow-up study visits. Life expectancy less than 3 months. Women who are pregnant or intend to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reprieve Decongestion Management System<br>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<br>* 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.<br>|
| Active Comparator: Optimal Diuretic Therapy<br>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<br>* Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).<br>|

What is the study measuring?
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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. | Through study completion, an average of 90 days | 

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, an average of 72 hours | 
| Time on loop diuretics | Total time on loop diuretics during primary treatment | End of treatment, an average of 72 hours |