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

Prior treatment

• 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.

Other illness

• Dyspnea due primarily to non-cardiac causes.
• Acute infection with evidence of systemic involvement.
• 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.
• Presence of active coronavirus disease 2019 (COVID-19) infection.

Lab values

• Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.

Other

• Inability to place Foley catheter or IV catheter.
• Hemodynamic instability.
• Inability to follow instructions or comply with follow-up procedures.
• Severe electrolyte abnormalities.
• Enrollment in another interventional trial during the index hospitalization.
• Inability to return for follow-up study visits.
• Life expectancy less than 3 months.
• Women who are pregnant or intend to become pregnant.

• 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.
• ≥ 18 years of age able to provide informed consent and comply with study procedures.