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

Renal Insufficiency Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02324400
• Other study ID #: PRNS003
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: December 11, 2014
• Last updated: December 18, 2014
• Start date: January 2015

Study information

• Verified date: December 2014
• Source: Nephera Ltd.
• Contact: Yotam Reisner, MD, PhD
• Phone: +97246373797
• Email: yotam[@]nephera.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure
• Heart Failure, Congestive
• Renal Insufficiency

Intervention

Device:
• RenaSense Stimulation
RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
• RenaSense Sham Control
RenaSense Catheter,no delivery of stimulation

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa	Outside USA
Israel	Hillel Yaffe Medical Center	Hedera
Israel	Ziv Medical Center	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Nephera Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dosage of Furosemide administration		72 hours	No
Other	Dyspnea score as assessed by Likert scale		72 hours	No
Other	Body weight		72 hours	No
Other	Fractional excretion of Sodium		24, 48 and 72 hours	No
Other	Serum brain natriuretic peptide (BNP) values following 48 and 72 hours of treatment		48 and 72 hours	No
Other	Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) following 72 hours of treatment as compared to baseline		72 hours	Yes
Primary	Number of Participants with unanticipated adverse events as a measure of safety and tolerability		72 hours	Yes
Secondary	Renal Function as Assessed by Serum Cystatin C level		24, 48 and 72 hours	No
Secondary	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	Yes
Secondary	Sum of Global Rank Score following 72 hours of treatment as compared to baseline		72 hours	No
Secondary	Urine volume	Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment	24, 48 and 72 hours	No