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

N

Nephera

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Heart Decompensation
Heart Failure, Congestive
Renal Insufficiency

Treatments

Device: RenaSense Sham Control
Device: RenaSense Stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02324400
PRNS003

Details and patient eligibility

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

36 estimated patients

Sex

Female

Ages

18 to 85 years old

Volunteers

No Healthy 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:

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
  • Indication for urinary catheterization
  • BNP > 400 pg/mL at initial evaluation
  • Able and willing to sign the informed consent

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)
  • 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
  • Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

36 participants in 2 patient groups

Treatment
Active Comparator group
Treatment:
Device: RenaSense Stimulation
Control
Sham Comparator group
Treatment:
Device: RenaSense Sham Control

Trial contacts and locations

0

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Central trial contact

Yotam Reisner, MD, PhD

Data sourced from clinicaltrials.gov

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