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Selective Cytopheretic Device (SCD) Trial

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ClinicalTrials.gov Identifier: NCT03836482
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Keith Aaronson, University of Michigan

Brief Summary:

The purpose of this study is to evaluate the selective cytopheretic device on the immune dysregulated state of congestive heart failure(CHF) with CRS and to assess the benefit of the device to improve cardiovascular and renal function. The study will enroll eligible patients in the ICU with acute on chronic systolic heart failure and worsening renal function due to cardiorenal syndrome while awaiting LVAD implantation.

In this study patients who are eligible and agree to participate will receive treatment with the SCD. The treatment will be for 6 hours a day up to 6 days. Additionally, participants will have additional study procedures and be evaluated to determine if their kidney function improves enough to undergo LVAD implantation.


Condition or disease Intervention/treatment Phase
Acute on Chronic Systolic Congestive Heart Failure Cardiorenal Syndrome Device: Selective Cytopheretic Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device to Treat ICU Patients With Acute or Chronic Systolic Heart Failure With Cardiorenal Syndrome(CRS) Awaiting Left Ventricular Assist Device (LVAD) Implantation
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Selective Cytopheretic Device Device: Selective Cytopheretic Device
Treatment will be delivered for 6 hours a day for up to 6 consecutive days.




Primary Outcome Measures :
  1. Percent of patients with reversal of Worsening Renal Function (WRF) [ Time Frame: up to 30 days after the last SCD treatment or LVAD ]
    WRF (≥ 0.5 mg/dL reduction of serum creatinine from level at study entry), and achieving an Estimated Glomerular Filtration Rate (eGFR) > 30 ml/min/1.73 m2 and Pulmonary Capillary Wedge (PCW) at or below level at study entry at termination of SCD therapy.


Secondary Outcome Measures :
  1. Percentage of subject receiving a left ventricular assist device [ Time Frame: up to 30 days after the last SCD ]
  2. Change in 24 hour urine volume [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  3. Change in urine sodium [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  4. Change in urine creatinine [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  5. Change in urine urea [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  6. Change in creatinine clearance [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  7. Change in urine urea clearance [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  8. Change in Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
    If PCWP cannot be obtained, Pulmonary Artery Diastolic Pressure (PADP) will be used in its place. When utilizing PADP in place of PCWP for change measures, comparisons will be made to baseline PADP.

  9. Change in serum sodium [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  10. Change in serum potassium [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  11. Change in serum dissolved carbon dioxide (CO2) [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  12. Change in blood urea nitrogen (BUN) [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  13. Change in serum creatinine [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
  14. Percentage of subjects with reduction of serum creatinine (≥ 0.5 mg/dL) and PCWP (≤ 18 mmHg) [ Time Frame: change from onset of intervention to 3 and 6 days after initiation of SCD treatments and from onset of intervention to end of SCD support prior to LVAD implantation ]
    If PCWP cannot be obtained, PADP will be used in its place. When utilizing PADP in place of PCWP for change measures, comparisons will be made to baseline PADP

  15. Percentage of subjects receiving a left ventricular assist device with serum creatinine ≥ 0.5 mg/dL below level at study entry [ Time Frame: 30 days following discontinuation of SCD ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary hospitalization for acute decompensated chronic systolic heart failure
  • Potential LVAD candidate with:

    • Left ventricular ejection fraction (LVEF) ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure
    • New York Heart Association (NYHA) class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, Angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) or valsartan/sacubitril, aldosterone antagonist, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days
    • Known previous peak exercise oxygen consumption < 14 mL/Kg/min or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)
  • Baseline eGFR** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)
  • Worsening renal failure (WRF), defined for the purposes of this study as

    • Increase serum creatinine ≥ 0.5 mg/dL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment) AND
    • eGFR** ≤ 30 ml/min/1.73 m2 based on serum creatinine at enrollment
  • Cardiorenal syndrome is the most likely explanation for WRF
  • Intolerant or inadequately responsive to standard of care diuretic therapy
  • Pulmonary Artery catheter in place at the time of enrollment
  • PCW greater or equal to 20mmHg (millimeters of mercury)

Exclusion Criteria:

  • Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
  • Prior sensitivity to dialysis device components
  • Bacteremia
  • Temperature ≥ 101.5 or white blood cells (WBC) ≥ 10,000 or any patient with suspected systemic infection
  • Active malignancy requiring chemotherapy, biological therapy or radiation therapy
  • The use of intravenous iodinated contrast agent within the prior 72 hours or the anticipated use of such an agent during SCD therapy
  • Persistent Systolic Blood Pressure < 80 mmHg
  • WBC < 4000
  • Platelets < 100,000
  • Serum creatinine > 4 mg/dL or receiving dialysis / Continuous Renal Replacement Therapy (CRRT)
  • Acute coronary syndrome within the past month
  • Women who are pregnant, breastfeeding a child, or trying to become pregnant.
  • Use of any other investigational drug or device within the previous 30 days
  • Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine > 3 mcg/kg/min. (Note: use of vasodilating inotropes [i.e., dobutamine and milrinone] or dobutamine at ≤ 3 mcg/kg/min will not preclude study inclusion)
  • Subject not able to sign informed consent
  • Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836482


Contacts
Contact: Neha Shah 734-232-4606 neshah@umich.edu
Contact: Keith Aaronson, MD 734-998-7991 keith@umich.edu

Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Keith Aaronson, MD University of Michigan

Responsible Party: Keith Aaronson, Collegiate Professor of Cardiovascular Medicine and Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03836482     History of Changes
Other Study ID Numbers: HUM00143014
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Keith Aaronson, University of Michigan:
Awaiting Left ventricular assist device implantation
Hospitalized

Additional relevant MeSH terms:
Syndrome
Heart Failure
Cardio-Renal Syndrome
Heart Failure, Systolic
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases