Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients
NCT ID: NCT02324400
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
RenaSense Stimulation
RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
Control
RenaSense Sham Control
RenaSense Catheter,no delivery of stimulation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RenaSense Stimulation
RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
RenaSense Sham Control
RenaSense Catheter,no delivery of stimulation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-85 years
3. Admitted to the hospital with a primary diagnosis of decompensated heart failure
4. Estimated glomerular filtration rate (GFR)\* ≤60 ml/min and ≥20 ml/min, based on serum creatinine at initial evaluation
5. History of chronic use of oral loop diuretics (≥ 80 mg/day Furosemide or equivalent) during the past 3 months
6. Indication for treatment with intravenous diuretics
7. 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
8. Indication for urinary catheterization
9. BNP \> 400 pg/mL at initial evaluation
10. Able and willing to sign the informed consent
Exclusion Criteria
2. Gross hematuria, perineal hematoma or symptomatic microscopic hematuria
3. Hypertension, systolic \>180 mmHg or diastolic \> 110 mmHg
4. Hypotension, systolic pressure \<100 mmHg
5. Status post renal denervation
6. Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD)
7. Suspected or known pregnancy
8. Previous organ transplantation
9. Life threatening condition such as severe infection, malignancy or infarction
10. Subject is participating in other concurrent clinical investigation
11. Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial
18 Years
85 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nephera Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rambam Health Care Campus
Haifa, Outside USA, Israel
Hillel Yaffe Medical Center
Hedera, , Israel
Ziv Medical Center
Safed, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRNS003
Identifier Type: -
Identifier Source: org_study_id