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

• 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.
• Diuretic (Drug): Best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC).

Primary outcomes

• Total Urine Sodium Output [24 hours post-treatment initiation]: Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
• Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency. [End of treatment, 0-72 hours.]: 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.

Secondary outcomes

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

Sex: All, ages: 18 Years to any

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.

Participant flow

Outcome results

• Total Urine Sodium Output (Primary), Mean, mmol of sodium: Reprieve Decongestion Management System 1082 +/- 487; Optimal Diuretic Therapy 423 +/- 290 (p <0.001)
• Clinically Significant Acute Kidney Injury, Severe Electrolyte Abnormality, Symptomatic Hypotension or Hypertensive Emergency. (Primary), Number, total number of events: Reprieve Decongestion Management System 16; Optimal Diuretic Therapy 19 (p 0.43)
• Net Fluid Loss (Secondary), Mean, liters: Reprieve Decongestion Management System 8.1 +/- 5.7; Optimal Diuretic Therapy 8.1 +/- 7.1
• Time on IV Loop Diuretics (Secondary), Median, hours: Reprieve Decongestion Management System 46 (29 to 80); Optimal Diuretic Therapy 88 (44 to 143)

Adverse events

Time frame: From enrollment until end of follow up, up to 90 days

Serious adverse events by term

Other adverse events by term

• Results publication: 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 Aug;14(8):103062. doi: 10.1016/j.jchf.2026.103062. Epub 2026 May 1. PMID 42068320
• Results publication: 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. PMID 40295876

• Study Protocol and Statistical Analysis Plan (PDF, 2023-09-05)

• James E. Udelson, MD, Principal investigator, Division of Cardiology and the CardioVascular Center, Tufts Medical Center