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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02324400
Other study ID # PRNS003
Secondary ID
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. completion date
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


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
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