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

Nephera

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Heart Decompensation; Heart Failure, Congestive; Renal Insufficiency

Treatments: Device: RenaSense Sham Control; Device: RenaSense Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02324400

PRNS003

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. History of urinary tract infection within the last 1 month based on medical history and/or urinalysis on day of admission
2. Gross hematuria, perineal hematoma or symptomatic microscopic hematuria
3. Hypertension, systolic >180 mmHg or diastolic > 110 mmHg
4. Hypotension, systolic pressure <100 mmHg
5. Status post renal denervation
6. Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD)
7. Suspected or known pregnancy
8. Previous organ transplantation
9. Life threatening condition such as severe infection, malignancy or infarction
10. Subject is participating in other concurrent clinical investigation
11. Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Treatment

Active Comparator group

Treatment:

Device: RenaSense Stimulation

Control

Sham Comparator group

Treatment:

Device: RenaSense Sham Control