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

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.

Study Overview

• Status: Unknown
• Conditions: Renal Insufficiency; Heart Failure, Congestive; Heart Decompensation
• Intervention / Treatment: Device: RenaSense Stimulation; Device: RenaSense Sham Control

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Hedera, Israel, 3810101
    • Hillel Yaffe Medical Center
  • Safed, Israel, 13100
    • Ziv Medical Center
  • Outside USA
    • Haifa, Outside USA, Israel, 31096
      • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control	Device: RenaSense Sham Control; RenaSense Catheter,no delivery of stimulation
Active Comparator: Treatment	Device: RenaSense Stimulation; RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Dosage of Furosemide administration	72 hours
Dyspnea score as assessed by Likert scale	72 hours
Body weight	72 hours
Fractional excretion of Sodium	24, 48 and 72 hours
Serum brain natriuretic peptide (BNP) values following 48 and 72 hours of treatment	48 and 72 hours
Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) following 72 hours of treatment as compared to baseline	72 hours

Collaborators and Investigators

• Sponsor: Nephera Ltd.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 18, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Estimate): December 24, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Heart Failure; Renal Insufficiency
• Other Study ID Numbers: PRNS003