Selective Cytopheretic Device (SCD) Trial

Cardiorenal Syndrome Clinical Trial

Official title:

Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device to Treat ICU Patients With Acute or Chronic Systolic Heart Failure With Cardiorenal Syndrome(CRS) Awaiting Left Ventricular Assist Device (LVAD) Implantation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03836482
• Other study ID #: HUM00143014
• Status: Suspended
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Primary hospitalization for acute decompensated chronic systolic heart failure

2. Potential LVAD candidate with:

1. Left ventricular ejection fraction =25% (for potential destination therapy) or = 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure

2. 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

3. 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)

3. Baseline eGFR** = 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)

4. 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

5. PA catheter in place at the time of enrollment

6. PCW = 20 mmHg

7. Age = 21and = 75 years

• eGFR calculated using the 4-variable MDRD 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. Bacteremia

4. Temperature = 101.5 F or WBC = 10,000 K/uL or any patient with suspected systemic infection.

5. Active malignancy requiring chemotherapy, biological therapy or radiation therapy

6. The use of intravenous iodinated contrast agent within the prior 72 hours or the anticipated use of such an agent during SCD therapy

7. 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)

8. Persistent SBP < 80 mmHg

9. WBC < 4000 K/uL

10. Platelets < 100,000K/uL

11. Serum creatinine > 4 mg/dL or receiving dialysis / CRRT

12. Acute coronary syndrome within the past month

13. Women who are pregnant, breastfeeding a child, or trying to become pregnant

14. Subject not able to sign informed consent, unless they have a legally authorized representative (LAR)

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

Related Conditions & MeSH terms

• Acute on Chronic Systolic Congestive Heart Failure
• Cardio-Renal Syndrome
• Cardiorenal Syndrome
• Heart Failure
• Syndrome
• Systolic Murmurs

Intervention

Device:
• Selective Cytopheretic Device
Treatment will be delivered for 6 hours a day for up to 6 consecutive days.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Lenar Yessayan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients with reversal of Worsening Renal Function (WRF)	WRF (= 0.5 mg/dL reduction of serum creatinine from level at study entry), and achieving an Estimated Glomerular Filtration Rate (eGFR) > 30 ml/min/1.73 m2 and Pulmonary Capillary Wedge (PCW) at or below level at study entry at termination of SCD therapy.	up to 30 days after the last SCD treatment or LVAD
Secondary	Percentage of subject receiving a left ventricular assist device		up to 30 days after the last SCD
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in creatinine clearance		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
Secondary	Change in urine urea clearance		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
Secondary	Change in Pulmonary Capillary Wedge Pressure (PCWP)	If PCWP cannot be obtained, Pulmonary Artery Diastolic Pressure (PADP) will be used in its place. When utilizing PADP in place of PCWP for change measures, comparisons will be made to baseline PADP.	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
Secondary	Change in serum 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
Secondary	Change in serum potassium		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
Secondary	Change in serum dissolved carbon dioxide (CO2)		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
Secondary	Change in blood urea nitrogen (BUN)		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
Secondary	Change in serum 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
Secondary	Percentage of subjects with reduction of serum creatinine (= 0.5 mg/dL) and PCWP (= 18 mmHg)	If PCWP cannot be obtained, PADP will be used in its place. When utilizing PADP in place of PCWP for change measures, comparisons will be made to baseline PADP	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
Secondary	Percentage of subjects receiving a left ventricular assist device with serum creatinine = 0.5 mg/dL below level at study entry		30 days following discontinuation of SCD