Heart Failure Clinical Trial
Selective Cytopheretic Device (SCD) Trial
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.
Primary hospitalization for acute decompensated chronic systolic heart failure
Potential LVAD candidate with:
Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure
NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or 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)
At least one of the following two criteria:
Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria
Central venous pressure > 16 mmHg
Central venous pressure/Pulmonary wedge pressure >0.65
Right ventricular stroke work index < 300 mmHg * ml/m2
Pulmonary artery pulsatility index (PAPi) < 2,
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*** AND
Cardiorenal syndrome is the most likely explanation for WRF AND
Intolerant or inadequately responsive to standard of care diuretic therapy
PA catheter in place at the time of enrollment
PCW ≥ 20 mmHg
Age ≥ 21and ≤ 75 years
eGFR calculated using the 4-variable MDRD equation *** Recognizing that this is not a steady state creatinine
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
Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL 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
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 dopamine at ≤ 3 mcg/kg/min will not preclude study inclusion)
Persistent SBP < 80 mmHg
WBC < 4000 K/uL
Platelets < 100,000K/uL
Serum creatinine > 4 mg/dL or receiving dialysis / CRRT
Acute coronary syndrome within the past month
Women who are pregnant, breastfeeding a child, or trying to become pregnant
Subject not able to sign informed consent, unless they have a legally authorized representative (LAR)
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
Use of any other investigational drug or device within the previous 30 days
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There is 1 Location for this study
Ann Arbor Michigan, 48109, United States
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