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

This is an interventional treatment trial for Cardiorenal Syndrome Read More

Inclusion Criteria:

1. Male or female patients ≥22 years of age
2. Patients admitted with primary diagnosis of ADHF

3. Persistent volume overload with venous congestion despite at least 24 hours of IV diuretic therapy, including either a single bolus ≥ 100 mg or continuous drip ≥ 10 mg/hour of furosemide equivalent, where:

   1. Volume overload defined by the presence of pulmonary edema, 2+ peripheral edema, or orthopnea
   2. Venous congestion defined by at least one of the following:

   i. Jugular venous pressure > 10 cm on physical exam ii. Central venous pressure > 10 mmHg iii. Pulmonary capillary wedge pressure > 22 mmHg c) Evidence of low natriuretic response to high dose diuretic therapy defined by spot urine sodium < 70 mmol

4. Ability to have the JuxtaFlow® System catheters placed at bedside
5. Anticipated to have an inpatient hospital admission that is ≥ 72 hours
6. Patients that are willing and able to provide informed consent for this research trial, or if the patient is not able to provide consent due to their clinical condition, a legal guardian, spouse, or next of kin to the patient with medical power of attorney that is willing to provide consent for the patient's participation in this research trial
7. Patients who agree to comply with the study procedures and specified evaluations

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