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

Phase 1

• Conditions: Heart Failure, Congestive; Heart Decompensation; Renal Insufficiency
• Interventions: Device: RenaSense Stimulation; Device: RenaSense Sham Control

• Registration Number: NCT02324400
• Lead Sponsor: Nephera Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-18
• Last Update Submitted: 2014-12-18
• Study First Posted: 2014-12-24
• Last Update Posted: 2014-12-24
• Study Start: 2015-01
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	RenaSense Stimulation	-
Control	RenaSense Sham Control	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with unanticipated adverse events as a measure of safety and tolerability	72 hours

Secondary Outcome Measures

Name	Time	Method
Renal Function as Assessed by Serum Cystatin C level	24, 48 and 72 hours
Sum of Global Rank Score following 72 hours of treatment as compared to baseline	72 hours
Urinary symptoms, hospitalizations and mortality	90 days	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
Urine volume	24, 48 and 72 hours	Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment

Trial Locations

Locations (3)

Hillel Yaffe Medical Center; 🇮🇱 Hedera, Israel

Rambam Health Care Campus; 🇮🇱 Haifa, Outside USA, Israel

Ziv Medical Center; 🇮🇱 Safed, Israel