Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF)
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StatusAccepting Candidates
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Age22 Years - N/A
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SexesAll
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Healthy VolunteersNo
Objective
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.
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.
Details
Full study title | Volume Optimization Incorporating Negative Pressure Diuresis in Heart Failure (VOID-HF) |
Protocol number | OCR39444 |
ClinicalTrials.gov ID | NCT04227977 |
Phase | N/A |
Eligibility
Inclusion Criteria:
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:
i. 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
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
Exclusion Criteria:
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
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
Lead researcher
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Alex M Parker, MDCardiologist (Heart Specialist), Advanced Heart Failure and Transplant Specialist
Participate in a study
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Step1
Contact the research team
Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.
Primary contact
Alex Parker -
Step2
Get screened to confirm eligibility
You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.
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Step3
Provide your consent to participate
If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.
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Step4
Participate
If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.