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

Nephera Ltd.3 sites in 1 country36 target enrollmentJanuary 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Heart Decompensation
Sponsor: Nephera Ltd.
Enrollment: 36
Locations: 3
Primary Endpoint: Number of Participants with unanticipated adverse events as a measure of safety and tolerability
Last Updated: 11 years ago

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

January 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Sponsor

Nephera Ltd.

Responsible Party

Sponsor

•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:
•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

•History of urinary tract infection within the last 1 month based on medical history and/or urinalysis on day of admission
•Gross hematuria, perineal hematoma or symptomatic microscopic hematuria
•Hypertension, systolic \>180 mmHg or diastolic \> 110 mmHg
•Hypotension, systolic pressure \<100 mmHg
•Status post renal denervation
•Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD)
•Suspected or known pregnancy
•Previous organ transplantation
•Life threatening condition such as severe infection, malignancy or infarction
•Subject is participating in other concurrent clinical investigation

Number of Participants with unanticipated adverse events as a measure of safety and tolerability

Time Frame: 72 hours

Renal Function as Assessed by Serum Cystatin C level(24, 48 and 72 hours)
Sum of Global Rank Score following 72 hours of treatment as compared to baseline(72 hours)
Urinary symptoms, hospitalizations and mortality(90 days)
Urine volume(24, 48 and 72 hours)