Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
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
Primary purpose
Allocation
Interventional model
Masking
36 participants in 2 patient groups
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Central trial contact
Yotam Reisner, MD, PhD
Data sourced from clinicaltrials.gov
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