Cardiorenal SyndromeVOID-HFNCT04227977
Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
A study testing JuxtaFlow System in people with Cardiorenal Syndrome, run by 3ive Labs at 4 sites in United States.
Trial summary
The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cardiorenal Syndrome
- What is being tested?
- JuxtaFlow System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jun 2020to 20 Oct 2023
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥22 years of age
- Patients admitted with primary diagnosis of ADHF
- Persistent volume overload with venous congestion despite at least 24 hours of IV diuretic therapy, including either a single bolus ≥ 100 mg or continuous drip ≥ 10 mg/hour of furosemide equivalent, where:
- Volume overload defined by the presence of pulmonary edema, 2+ peripheral edema, or orthopnea
- Venous congestion defined by at least one of the following:
- Jugular venous pressure > 10 cm on physical exam ii. Central venous pressure > 10 mmHg iii. Pulmonary capillary wedge pressure > 22 mmHg c) Evidence of low natriuretic response to high dose diuretic therapy defined by spot urine sodium < 70 mmol
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- Ability to have the JuxtaFlow® System catheters placed at bedside
- Anticipated to have an inpatient hospital admission that is ≥ 72 hours
- Patients that are willing and able to provide informed consent for this research trial, or if the patient is not able to provide consent due to their clinical condition, a legal guardian, spouse, or next of kin to the patient with medical power of attorney that is willing to provide consent for the patient's participation in this research trial
- Patients who agree to comply with the study procedures and specified evaluations
Who cannot join
- Females who are pregnant or nursing mothers
- Creatinine > 3.0 mg/dL at admission to the hospital
- Systolic blood pressure < 100 mmHg at the time of enrollment
- Clinical instability likely to require the addition of intravenous vasoactive drugs, vasodilators and/or inotropic agents.
- Alternative explanation for the renal impairment causing the persistent volume overload, such as obstructive nephropathy, contrast induced nephropathy, or acute tubular necrosis
- Any patient with an eGFR < 15 ml/min or prior diagnosis of CKD 5
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- Any patient presenting with hematuria as defined by urine dipstick reading of > 1+ blood
- Any patient presenting with proteinuria as defined by urine dipstick reading of > 3+ protein.
- Any patient that would not potentially benefit from this therapy in the opinion of the investigator
- Any patient with a current upper or lower urinary tract infection (tested during pre-screening)
- Any patient with a malignancy of the upper urinary tract
- Any patient who are currently experiencing unexplained/unexpected proteinuria as determined by the investigator
- Any patient with a current unrepaired ureteral avulsion as determined by the investigator
- Any patient that would require an MRI between enrollment and completion of the post-treatment baseline period
- Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
- Any use of an iodinated radiocontrast material in the past 72 hours prior to study enrollment or anticipated use of intravenous contrast during the current hospitalization.
- Pre-enrollment ultrasound revealing any of the following:
- Congenital abnormality in either kidney
- Only one kidney
- Presence of debris, stones or an obstruction in the renal pelvis, ureter or urinary tract
- Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cleveland Clinic
Cleveland, Ohio, 44195
University of Florida
Gainesville, Florida, 32611
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Univ. of Texas Health
San Antonio, Texas, 78229
About this study
The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The aims and purpose of this feasibility clinical research trial are: 1. to evaluate the safety profiles associated with performing negative pressure diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow System in treatment of hypervolemia associated with ADHF.
Read the detailed description
The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The primary renal adjuvant therapies for presistent congestion despite high dose IV diuretic therapy are ultrafiltration and dialysis. Unfortunately, clinical decongestion is uncommon in this population despite aggressive therapies. Negative pressure diuresis in the renal pelvis has the potential to treat hypervolemia associated with ADHF by increasing renal filtration and increased urine output.
Primary endpoint: The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment actuarial follow up.
Secondary endpoints: a) Increase in urine output from baseline to discontinuation of treatment with the JuxtaFlow System. b) Reduction of congestion (as measured by change in BNP) during the course of the treatment with the JuxtaFlow System. c) The relative change in creatinine clearance from baseline to treatment period after 24 hours of treatment or until discontinuation of the investigational treatment using each study subject as their own control. The change in creatinine clearance from the baseline period to the 24 hour post End of Treatment (EOT) period.
- Conditions
- Cardiorenal Syndrome
- Being tested
- JuxtaFlow System
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JuxtaFlow SystemDevice
The JuxtaFlow System consists of proprietary ureteral catheters deployed endoscopically over the wire to deliver mild controlled negative pressure into the renal pelvis.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | JuxtaFlow Receives: Device: JuxtaFlow System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related adverse events
The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment follow up.
Measured: 28 days
Secondary outcomes (3)
Urine output
The change in urine output from baseline to discontinuation
Measured: 24 hours
Congestion
The change in congestion (as measured by change in BNP) during the course of treatment
Measured: 24 hours
Creatinine Clearance
The change in creatinine clearance from baseline to discontinuation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start12 Jun 2020
- Primary completion1 May 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorenal SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3ive Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilson Tang, MD, Principal investigator, The Cleveland ClinicAlex Parker, MD, Principal investigator, Univ. of Florida, GainesvilleWayne Old, MD, Principal investigator, Sentara Norfolk General HospitalShweta Bansal, MD, Principal investigator, Univ. of Texas Health, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227977
- Sponsor's protocol ID
- VOID-HF
- Acronym
- VOID-HF
- Status last verified
- Oct 2023
- First submitted
- 10 Jan 2020
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
- ClinicalTrials.gov ID
- NCT04227977
- Acronym / sponsor ID
- VOID-HF / VOID-HF
- Conditions
- Cardiorenal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- 3ive LabsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 14 Jan 2020 (actual)
- 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 Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The aims and purpose of this feasibility clinical research trial are: 1. to evaluate the safety profiles associated with performing negative pressure diuresis for the treatment of hypervolemia associated with the cardiorenal syndrome during ADHF with persistent congestion despite high dose IV diuretic therapy via the investigational JuxtaFlow® System, and 2. to evaluate the effectiveness of the investigational JuxtaFlow System in treatment of hypervolemia associated with ADHF.
Detailed description
The Cardiorenal Syndrome during Acute decompensated heart failure (ADHF) with persistent congestion despite high dose IV diuretic therapy is associated with remarkable morbidity, which can include the need for renal dialysis or ultrafiltration, an increased length of stay, and high mortality rates. The primary renal adjuvant therapies for presistent congestion despite high dose IV diuretic therapy are ultrafiltration and dialysis. Unfortunately, clinical decongestion is uncommon in this population despite aggressive therapies. Negative pressure diuresis in the renal pelvis has the potential to treat hypervolemia associated with ADHF by increasing renal filtration and increased urine output.
Primary endpoint: The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment actuarial follow up.
Secondary endpoints: a) Increase in urine output from baseline to discontinuation of treatment with the JuxtaFlow System. b) Reduction of congestion (as measured by change in BNP) during the course of the treatment with the JuxtaFlow System. c) The relative change in creatinine clearance from baseline to treatment period after 24 hours of treatment or until discontinuation of the investigational treatment using each study subject as their own control. The change in creatinine clearance from the baseline period to the 24 hour post End of Treatment (EOT) period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: JuxtaFlow SystemJuxtaFlow |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female patients ≥22 years of age
- Patients admitted with primary diagnosis of ADHF
- Persistent volume overload with venous congestion despite at least 24 hours of IV diuretic therapy, including either a single bolus ≥ 100 mg or continuous drip ≥ 10 mg/hour of furosemide equivalent, where:
- Ability to have the JuxtaFlow® System catheters placed at bedside
- Anticipated to have an inpatient hospital admission that is ≥ 72 hours
Key exclusion criteria (21 listed)
- Females who are pregnant or nursing mothers
- Creatinine > 3.0 mg/dL at admission to the hospital
- Systolic blood pressure < 100 mmHg at the time of enrollment
- Clinical instability likely to require the addition of intravenous vasoactive drugs, vasodilators and/or inotropic agents.
- Alternative explanation for the renal impairment causing the persistent volume overload, such as obstructive nephropathy, contrast induced nephropathy, or acute tubular necrosis
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 |
|---|---|---|
| JuxtaFlow SystemThe JuxtaFlow System consists of proprietary ureteral catheters deployed endoscopically over the wire to deliver mild controlled negative pressure into the renal pelvis. | Device | Treatment |
Primary outcome
Device related adverse events
Time frame: 28 days
The characterization of the type, frequency, severity, and device-relatedness of adverse events (AEs) associated with the placement, use, and removal of the JuxtaFlow System and a 28-day post-treatment follow up.
3 secondary outcomes
Urine output
Time frame: 24 hours
Congestion
Time frame: 24 hours
Creatinine Clearance
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiorenal Syndrome
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Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
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Not yet recruitingPhase 3
Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal
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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.
Wilson Tang, MD principal investigator
The Cleveland Clinic
Alex Parker, MD principal investigator
Univ. of Florida, Gainesville
Wayne Old, MD principal investigator
Sentara Norfolk General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JuxtaFlow System in people with Cardiorenal Syndrome, run by 3ive Labs at 4 sites in United States.
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 10 inclusion and 21 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: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device related adverse events (time frame: 28 days). 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 25 Oct 2023.