Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD

NCT03836482 | Recruiting DMC FDA Device

• 2 other identifiers: SCD-CRS-011R44HL170779-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiorenal Syndrome; Acute on Chronic Systolic Congestive Heart Failure

Keywords

Awaiting Left ventricular assist device implantation; Hospitalized; Selective Cytopheretic Device; SCD; LVAD; CRS

Outcome Measures

Primary Outcomes (6)

• Need for continuous IV vasopressor support

  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.)

  measured daily, at or after 4 hours after termination of daily SCD therapy

• Acute myocardial infarction

  Acute myocardial infarction as evidenced by elevated cardiac enzymes, with electrocardiographic or imaging findings consistent with myocardial damage and confirmed by Cardiology.

  up to 6 months following SCD treatment initiation

• Mortality

  Death

  up to 6 months following SCD treatment initiation

• Percentage of subjects with reversal of WRF and increase eGFR and PCW

  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.

  up to 6 days after initiation of SCD therapy

• Percentage of subjects who no longer have severe right ventricular failure

  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

  up to 6 days after initiation of SCD therapy

• Adverse Events

  Adverse Events due to SCD, hemodialysis catheter, KRT pump, circuit, and hemofilter

  up to 6 days after initiation of SCD therapy

Secondary Outcomes (16)

• Percentage of subject receiving a left ventricular assist device

  up to 30 days after the last SCD

• Change in 24 hour urine volume

  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

• Change in urine sodium

  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

• Change in urine creatinine

  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

• Change in urine urea

  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

Study Arms (1)

Selective Cytopheretic Device

EXPERIMENTAL

Device: Selective Cytopheretic Device

Interventions

Selective Cytopheretic Device DEVICE

Treatment will be delivered for 4 hours a day for up to 6 consecutive days.

Selective Cytopheretic Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)
• 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, 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.

You may not qualify if:

• 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
• Patients requiring mechanical ventilatory support
• Patients requiring total parenteral nutrition during the treatment period
• 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
• 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. 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.

Sponsors & Collaborators

• University of Michigan: collaborator
• Innovative BioTherapies (IBT): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• SeaStar Medical: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: October 2, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)