NCT02324400

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

December 24, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 11, 2014

Last Update Submit

December 18, 2014

Conditions

Heart DecompensationHeart Failure, CongestiveRenal Insufficiency

Outcome Measures

Primary Outcomes (1)

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

    72 hours

Secondary Outcomes (4)

  • Renal Function as Assessed by Serum Cystatin C level

    24, 48 and 72 hours

  • Urinary symptoms, hospitalizations and mortality

    90 days

  • Sum of Global Rank Score following 72 hours of treatment as compared to baseline

    72 hours

  • Urine volume

    24, 48 and 72 hours

Other Outcomes (6)

  • Dosage of Furosemide administration

    72 hours

  • Dyspnea score as assessed by Likert scale

    72 hours

  • Body weight

    72 hours

  • +3 more other outcomes

Study Arms (2)

Treatment

ACTIVE COMPARATOR
Device: RenaSense Stimulation

Control

SHAM COMPARATOR
Device: RenaSense Sham Control

Interventions

RenaSense StimulationDEVICE

RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall

Treatment
RenaSense Sham ControlDEVICE

RenaSense Catheter,no delivery of stimulation

Control

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rambam Health Care Campus

Haifa, Outside USA, 31096, Israel

Location

Hillel Yaffe Medical Center

Hedera, 3810101, Israel

Location

Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Heart FailureRenal Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Yotam Reisner, MD, PhD

CONTACT

+97246373797yotam@nephera.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 24, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Last Updated

December 24, 2014

Record last verified: 2014-12

Locations

IL(3)