Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD (NCT03836482) | Clinical Trial Compass
RecruitingNot Applicable
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
United States20 participantsStarted 2025-10-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age of 18 years and older.
. Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0.
. Primary hospitalization for acute decompensated chronic systolic heart failure.
. Potential LVAD candidate with:
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Need for continuous IV vasopressor support
Timeframe: measured daily, at or after 4 hours after termination of daily SCD therapy
2
Acute myocardial infarction
Timeframe: up to 6 months following SCD treatment initiation
3
Mortality
Timeframe: up to 6 months following SCD treatment initiation
4
Percentage of subjects with reversal of WRF and increase eGFR and PCW
Timeframe: up to 6 days after initiation of SCD therapy
5
Percentage of subjects who no longer have severe right ventricular failure
Timeframe: up to 6 days after initiation of SCD therapy
6
Adverse Events
Timeframe: up to 6 days after initiation of SCD therapy
Central venous pressure/Pulmonary wedge pressure \>0.65
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
. Active bacteremia
. Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
. Metastatic malignancy requiring palliative chemo, biologic, or radiation
. 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)
. Patients requiring mechanical ventilatory support
. Patients requiring total parenteral nutrition during the treatment period