Heart DecompensationPhase 1/2NCT02324400
Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
A Phase 1/2 study testing RenaSense Stimulation in people with Heart Decompensation and Heart Failure, Congestive, run by Nephera Ltd. at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Heart Decompensation, Heart Failure, Congestive, Renal Insufficiency
- What is being tested?
- RenaSense Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
3 sites in 1 country.
Israel3 sites
Rambam Health Care Campus
Haifa, Outside USA, 31096
Hillel Yaffe Medical Center
Hedera, 3810101
Ziv Medical Center
Safed, 13100
About this study
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.
- Being tested
- RenaSense Stimulation, RenaSense Sham Control
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenaSense StimulationDevice
RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
RenaSense Sham ControlDevice
RenaSense Catheter,no delivery of stimulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Not described Receives: Device: RenaSense Stimulation |
| Control | Sham comparator | Not described Receives: Device: RenaSense Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with unanticipated adverse events as a measure of safety and tolerability
Measured: 72 hours
Secondary outcomes (4)
Renal Function as Assessed by Serum Cystatin C level
Measured: 24, 48 and 72 hours
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
Measured: 90 days
Sum of Global Rank Score following 72 hours of treatment as compared to baseline
Measured: 72 hours
Urine volume
Urine output volume collected over 24 hour intervals during days 1 to 3 of treatment
Measured: 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DecompensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nephera Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324400
- Sponsor's protocol ID
- PRNS003
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 24 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02324400
- Acronym / sponsor ID
- PRNS003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nephera Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: RenaSense Stimulation |
| Control | Sham comparator | Device: RenaSense Sham Control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenaSense StimulationRenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall | Device | Treatment |
| RenaSense Sham ControlRenaSense Catheter,no delivery of stimulation | Device | Control |
Primary outcome
Number of Participants with unanticipated adverse events as a measure of safety and tolerability
Time frame: 72 hours
4 secondary outcomes
Renal Function as Assessed by Serum Cystatin C level
Time frame: 24, 48 and 72 hours
Urinary symptoms, hospitalizations and mortality
Time frame: 90 days
Sum of Global Rank Score following 72 hours of treatment as compared to baseline
Time frame: 72 hours
Urine volume
Time frame: 24, 48 and 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RenaSense Stimulation in people with Heart Decompensation and Heart Failure, Congestive, run by Nephera Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yotam Reisner, MD, PhD (+97246373797, yotam@nephera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with unanticipated adverse events as a measure of safety and tolerability (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2014.