Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients

Inclusion Criteria

• •1. Females
• •2. Age 18-85 years
• •3. Admitted to the hospital with a primary diagnosis of decompensated heart failure
• •4. Estimated glomerular filtration rate (GFR)\* ≤60 ml/min and ≥20 ml/min, based on serum creatinine at initial evaluation
• •5. History of chronic use of oral loop diuretics (≥ 80 mg/day Furosemide or equivalent) during the past 3 months
• •6. Indication for treatment with intravenous diuretics
• •7. Volume overload
• •For patients with a pulmonary artery catheter, persistent volume overload will include:
• •* Pulmonary capillary wedge pressure greater than 22mmHg and one of the following clinical signs:
• •* at least 2+ peripheral edema and/or
• •* Pulmonary edema or pleural effusions on chest x-ray
• •For patients without a pulmonary artery catheter, persistent volume overload will include at least two of the following:
• •* At least 2+ peripheral edema
• •* Jugular venous pressure greater than 10 cm on physical examination (or central venous pressure greater than 10 mmHg when measured)
• •* pulmonary edema or pleural effusions on chest x-ray
• •8. Indication for urinary catheterization
• •9. BNP \> 400 pg/mL at initial evaluation
• •10. Able and willing to sign the informed consent