Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)

Exclusion Criteria

• •1. Females who are pregnant or nursing mothers
• •2. Creatinine \> 3.0 mg/dL at admission to the hospital
• •3. Systolic blood pressure \< 100 mmHg at the time of enrollment
• •4. Clinical instability likely to require the addition of intravenous vasoactive drugs, vasodilators and/or inotropic agents.
• •5. Alternative explanation for the renal impairment causing the persistent volume overload, such as obstructive nephropathy, contrast induced nephropathy, or acute tubular necrosis
• •6. Any patient with an eGFR \< 15 ml/min or prior diagnosis of CKD 5
• •7. Any patient presenting with hematuria as defined by urine dipstick reading of \> 1+ blood
• •8. Any patient presenting with proteinuria as defined by urine dipstick reading of \> 3+ protein.
• •9. Any patient that would not potentially benefit from this therapy in the opinion of the investigator
• •10. Any patient with a current upper or lower urinary tract infection (tested during pre-screening)
• •11. Any patient with a malignancy of the upper urinary tract
• •12. Any patient who are currently experiencing unexplained/unexpected proteinuria as determined by the investigator
• •13. Any patient with a current unrepaired ureteral avulsion as determined by the investigator
• •14. Any patient that would require an MRI between enrollment and completion of the post-treatment baseline period
• •15. Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
• •16. Any use of an iodinated radiocontrast material in the past 72 hours prior to study enrollment or anticipated use of intravenous contrast during the current hospitalization.
• •17. Pre-enrollment ultrasound revealing any of the following:
• •1. Congenital abnormality in either kidney
• •2. Only one kidney
• •3. Presence of debris, stones or an obstruction in the renal pelvis, ureter or urinary tract
• •18. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial