Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Condition(s) studied
Investigational drug(s) / intervention(s)
Selective Cytopheretic Device: Treatment will be delivered for 4 hours a day for up to 6 consecutive days.
Study summary
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.
This study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.
Eligibility
Primary outcome measure(s)
- Need for continuous IV vasopressor support — measured daily, at or after 4 hours after termination of daily SCD therapy
Need for continuous IV vasopressor support with \>5 total norepinephrine equivalents and/or \>3 vasopressor agents \>4 hours following termination of daily SCD therapy session to maintain a MAP \>60 mmHg, with norepinephrine equivalents defined as: 1. 1 x epinephrine (ug/kg/min) 2. 001 x dopamine (ug/kg/min) 3. 0.06 x phenylephrine (ug/kg/min) 4. 2.5 x vasopressin (U/min) (Note that use of inotropes (i.e., dobutamine and milrinone) or dopamine at ≤3 mcg/kg/min are not components of this measure.) - Acute myocardial infarction — up to 6 months following SCD treatment initiation
Acute myocardial infarction as evidenced by elevated cardiac enzymes, with electrocardiographic or imaging findings consistent with myocardial damage and confirmed by Cardiology. - Mortality — up to 6 months following SCD treatment initiation
Death - Percentage of subjects with reversal of WRF and increase eGFR and PCW — up to 6 days after initiation of SCD therapy
Among patients with WRF, the percentage of subjects with reversal of WRF (≥ 0.5 mg/dL reduction of serum creatinine from level at study entry), and achieving an eGFR \> 30 ml/min/1.73 m2 and PCWP at or below level at study entry at termination of SCD therapy. - Percentage of subjects who no longer have severe right ventricular failure — up to 6 days after initiation of SCD therapy
Among subjects with severe RVF, the percentage of subjects who no longer have severe right ventricular failure, as evidenced by absence of 3 or more of the following 4 indicators of right ventricular failure: 1. CVP \> 16 mmHg 2. CVP/PCWP \> 0.65 3. RVSWI \< 300 mmHg \* mL/m 4. PAPi \< 2 - Adverse Events — up to 6 days after initiation of SCD therapy
Adverse Events due to SCD, hemodialysis catheter, KRT pump, circuit, and hemofilter
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03836482 on ClinicalTrials.gov ↗ ← All trials in the USA