RecruitingNot applicable

Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD

Feasibility Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute on Chronic Systolic Heart Failure With Worsening Renal Function Due to Cardiorenal Syndrome or Severe Right Ventricular Failure Awaiting Left Ventricular Assist Device Implantation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of the Selective Cytopheretic Device (SCD), which treats blood outside the body to reduce inflammation. It may help heart or kidney function in adults with severe heart failure who might qualify for an LVAD, a pump that helps the heart work. Treatment lasts 4 hours a day for up to 6 days, with follow-up for 6 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with blood tests showing inflammation at the study’s required levels.
  • In the hospital mainly because long-term heart failure has suddenly gotten worse.
  • May qualify for an LVAD, with a heart pumping level of 25% or less, or 35% or less if awaiting a heart transplant.
  • Have severe heart failure that has not improved with the best tolerated medicines for 45 of the past 60 days.
  • Have low oxygen use during exercise, or cannot exercise and need certain heart-support devices or medicines, unless those medicines are unsafe.
  • Have a past kidney filtering score (eGFR) of at least 40, based on the highest score in the past 90 days.
  • Have severe failure of the heart’s right side, or worsening kidney failure linked to heart failure, meeting the study’s test limits. For kidney failure, water-removing medicines must not work well enough or cannot be tolerated.
  • Have a pressure-measuring tube in the lung artery and a lung blood-vessel pressure reading (PCW) of at least 20 mmHg.

Who can't join

  • Have a reason an LVAD would remain unsafe even if kidney function and fluid levels improve, or have had a reaction to dialysis device parts.
  • Have a bloodstream infection, suspected body-wide infection, fever of at least 101.5°F, or white blood cell counts outside the study’s limits.
  • Have cancer that has spread and needs treatment to ease symptoms rather than cure it.
  • Need certain IV medicines to raise blood pressure, dopamine above 3 mcg/kg/min, a breathing machine, or all nutrition through an IV during treatment.
  • Have a top blood pressure number that stays below 80, platelets below 100,000, creatinine above 4 mg/dL, or need dialysis. Platelets help blood clot; creatinine is a kidney blood test.
  • Had a sudden heart problem from reduced blood flow, such as a heart attack, within the past month.
  • Are pregnant, breastfeeding, or trying to become pregnant.
  • Are in another study testing a treatment, or used an experimental drug or device in the past 30 days. Studies that only collect measurements or samples are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age of 18 years and older. 2. Evidence of systemic inflammation: blood CRP ≥ 4.5 mg/L or IL-6 ≥ 5.0 pg/ml or neutrophil to lymphocyte ratio ≥3.0. 3. Primary hospitalization for acute decompensated chronic systolic heart failure. 4. Potential LVAD candidate with: a) Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure b) 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, SGLT2i, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days c) 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) 5. Baseline eGFR\*\* ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment) 6. At least one of the following two criteria: 1. 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, 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, defined as persistent signs and/or symptoms of congestion (e.g., peripheral edema, dyspnea, pulmonary rales, neck vein distension) or minimal net volume removal in a 24-hour period despite optimal medical therapy including intravenous diuretic therapy and an estimated need for \>5kg fluid removal. 1. Optimal intravenous diuretic therapy is defined as: 1. Furosemide equivalent total daily dose of 240mg 2. Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion 3. A furosemide equivalent total daily dose \<240mg if the dose has resulted in \>3000 mL urine output/24 hours. 7. PA catheter in place at the time of enrollment 8. PCW ≥ 20 mmHg * eGFR calculated using the CKD-EPI Creatinine Equation \*\*\* Recognizing that this is not a steady state creatinine Exclusion Criteria: 1. Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status 2. Prior sensitivity to dialysis device components 3. Active bacteremia 4. Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection. 5. Metastatic malignancy requiring palliative chemo, biologic, or radiation 6. 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) 7. Patients requiring mechanical ventilatory support 8. Patients requiring total parenteral nutrition during the treatment period 9. Persistent SBP \< 80 mmHg 10. WBC \< 4000 K/uL 11. Platelets \< 100,000K/uL 12. Serum creatinine \> 4 mg/dL or receiving dialysis / CRRT 13. Acute coronary syndrome within the past month 14. Women who are pregnant, breastfeeding a child, or trying to become pregnant 15. 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 16. Use of any other investigational drug or device within the previous 30 days. Patients who participated in a clinical study where only measurements and/or samples are taken (i.e., no test device or drug used) are allowed to participate.

Study sites (1)

MI