Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitali… (NCT02324400) | Clinical Trial CompassUnknownPhase 1/2
Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
Israel36 participantsStarted 2015-01 Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
- ✓. Indication for urinary catheterization
Exclusion criteria
- ✕. 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)
What they're measuring
1Number of Participants with unanticipated adverse events as a measure of safety and tolerability
Timeframe: 72 hours
Trial details
NCT IDNCT02324400
SponsorNephera Ltd.
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2016-01
Contact for this trial
Yotam Reisner, MD, PhD