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

Primary Purpose

Heart Decompensation, Heart Failure, Congestive, Renal Insufficiency

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

RenaSense Stimulation

RenaSense Sham Control

About this trial

This is an interventional treatment trial for Heart Decompensation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Rambam Health Care Campus
Hillel Yaffe Medical Center
Ziv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Renal Function as Assessed by Serum Cystatin C level

Urinary symptoms, hospitalizations and mortality

Assess no increase in urinary symptoms of obstruction or incontinence, hospitalizations and mortality rates following 30 days and 90 days follow-up, as compared to control with no electrical stimulation treatment

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

Urine volume

Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment

Full Information

NCT ID

NCT02324400

First Posted

December 11, 2014

Last Updated

December 18, 2014

Sponsor

Nephera Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02324400

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nephera Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Decompensation, Heart Failure, Congestive, Renal Insufficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Active Comparator

Arm Title

Control

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

RenaSense Stimulation

Intervention Description

RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall

Intervention Type

Device

Intervention Name(s)

RenaSense Sham Control

Intervention Description

RenaSense Catheter,no delivery of stimulation

Primary Outcome Measure Information:

Title

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

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Renal Function as Assessed by Serum Cystatin C level

Time Frame

24, 48 and 72 hours

Title

Urinary symptoms, hospitalizations and mortality

Description

Time Frame

90 days

Title

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

Time Frame

72 hours

Title

Urine volume

Description

Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment

Time Frame

24, 48 and 72 hours

Other Pre-specified Outcome Measures:

Title

Dosage of Furosemide administration

Time Frame

72 hours

Title

Dyspnea score as assessed by Likert scale

Time Frame

72 hours

Title

Body weight

Time Frame

72 hours

Title

Fractional excretion of Sodium

Time Frame

24, 48 and 72 hours

Title

Serum brain natriuretic peptide (BNP) values following 48 and 72 hours of treatment

Time Frame

48 and 72 hours

Title

Urine Neutrophil Gelatinase-Associated Lipocalin (NGAL) following 72 hours of treatment as compared to baseline

Time Frame

72 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yotam Reisner, MD, PhD

Phone

+97246373797

yotam@nephera.com

Facility Information:

Facility Name

Rambam Health Care Campus

City

Haifa

State/Province

Outside USA

ZIP/Postal Code

31096

Country

Israel

Facility Name

Hillel Yaffe Medical Center

City

Hedera

ZIP/Postal Code

3810101

Country

Israel

Facility Name

Ziv Medical Center

City

Safed

ZIP/Postal Code

13100

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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