Clinical trial NCT02324400: Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Heart Decompensation
Heart Failure, Congestive
Renal Insufficiency
Lead sponsor: Nephera Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with unanticipated adverse events as a measure of safety and tolerability
timeFrame: 72 hours
Secondary outcomes:
measure: Renal Function as Assessed by Serum Cystatin C level
timeFrame: 24, 48 and 72 hours
measure: Urinary symptoms, hospitalizations and mortality
timeFrame: 90 days
measure: Sum of Global Rank Score following 72 hours of treatment as compared to baseline
timeFrame: 72 hours
measure: Urine volume
timeFrame: 24, 48 and 72 hours
Other outcomes:
measure: Dosage of Furosemide administration
timeFrame: 72 hours
measure: Dyspnea score as assessed by Likert scale
timeFrame: 72 hours
measure: Body weight
timeFrame: 72 hours
measure: Fractional excretion of Sodium
timeFrame: 24, 48 and 72 hours
measure: Serum brain natriuretic peptide (BNP) values following 48 and 72 hours of treatment
timeFrame: 48 and 72 hours
measure: Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) following 72 hours of treatment as compared to baseline
timeFrame: 72 hours
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: Outside USA
city: Hedera
country: Israel
facility: Hillel Yaffe Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References: