Heart Decompensation, Heart Failure, Congestive, Renal Insufficiency
Conditions
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.
Interventions
DEVICERenaSense Stimulation
RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
DEVICERenaSense Sham Control
RenaSense Catheter,no delivery of stimulation
Sponsors
Nephera Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with unanticipated adverse events as a measure of safety and tolerability | 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function as Assessed by Serum Cystatin C level | 24, 48 and 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 |
| Sum of Global Rank Score following 72 hours of treatment as compared to baseline | 72 hours | — |
| Urine volume | 24, 48 and 72 hours | Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment |
Other
| Measure | Time frame |
|---|---|
| Dosage of Furosemide administration | 72 hours |
| Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) following 72 hours of treatment as compared to baseline | 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 |
Countries
Israel
Contacts
Primary ContactYotam Reisner, MD, PhD
Outcome results
None listed