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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RenaSense Stimulation | Device | RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with unanticipated adverse events as a measure of safety and tolerability | 72 hours |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dosage of Furosemide administration | 72 hours | |
| Dyspnea score as assessed by Likert scale | 72 hours | |
| Body weight |
Inclusion Criteria:
Females
Age 18-85 years
Admitted to the hospital with a primary diagnosis of decompensated heart failure
Estimated glomerular filtration rate (GFR)* ≤60 ml/min and ≥20 ml/min, based on serum creatinine at initial evaluation
History of chronic use of oral loop diuretics (≥ 80 mg/day Furosemide or equivalent) during the past 3 months
Indication for treatment with intravenous diuretics
Volume overload
For patients with a pulmonary artery catheter, persistent volume overload will include:
For patients without a pulmonary artery catheter, persistent volume overload will include at least two of the following:
Indication for urinary catheterization
BNP > 400 pg/mL at initial evaluation
Able and willing to sign the informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yotam Reisner, MD, PhD | Contact | +97246373797 | yotam@nephera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | Outside USA | 31096 | Israel | ||
| Hillel Yaffe Medical Center |
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| RenaSense Sham Control | Device | RenaSense Catheter,no delivery of stimulation |
|
| 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 |
| 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 |
| Hedera |
| 3810101 |
| Israel |
| Ziv Medical Center | Safed | 13100 | Israel |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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