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

Study Overview
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Brief Summary
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The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.

Conditions
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Heart Decompensation, Heart Failure, Congestive, Renal Insufficiency

Intervention / Treatment
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* Device: RenaSense Stimulation
* Device: RenaSense Sham Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females Age 18-85 years Admitted to the hospital with a primary diagnosis of decompensated heart failure Estimated glomerular filtration rate (GFR)* ≤60 ml/min and ≥20 ml/min, based on serum creatinine at initial evaluation History of chronic use of oral loop diuretics (≥ 80 mg/day Furosemide or equivalent) during the past 3 months Indication for treatment with intravenous diuretics 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 Indication for urinary catheterization BNP > 400 pg/mL at initial evaluation Able and willing to sign the informed consent Exclusion Criteria: History of urinary tract infection within the last 1 month based on medical history and/or urinalysis on day of admission Gross hematuria, perineal hematoma or symptomatic microscopic hematuria Hypertension, systolic >180 mmHg or diastolic > 110 mmHg Hypotension, systolic pressure <100 mmHg Status post renal denervation Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD) Suspected or known pregnancy Previous organ transplantation Life threatening condition such as severe infection, malignancy or infarction Subject is participating in other concurrent clinical investigation Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br> | Device: RenaSense Stimulation<br>* RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall<br>|
| Sham Comparator: Control<br> | Device: RenaSense Sham Control<br>* RenaSense Catheter,no delivery of stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with unanticipated adverse events as a measure of safety and tolerability |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function as Assessed by Serum Cystatin C level |  | 24, 48 and 72 hours | 
| Urinary symptoms, hospitalizations and mortality | Assess no increase in urinary symptoms of obstruction or incontinence, hospitalizations and mortality rates following 30 days and 90 days follow-up, as compared to control with no electrical stimulation treatment | 90 days | 
| Sum of Global Rank Score following 72 hours of treatment as compared to baseline |  | 72 hours | 
| Urine volume | Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment | 24, 48 and 72 hours |