Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD

Launched by SEASTAR MEDICAL · Feb 7, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called the Selective Cytopheretic Device (SCD) for patients who have severe heart failure combined with kidney problems, known as cardiorenal syndrome. Heart failure is a serious condition that affects the heart's ability to pump blood, and many patients with this condition do not respond well to traditional treatments. The purpose of this study is to see if the SCD can safely help improve heart and kidney function in patients who are waiting for a Left Ventricular Assist Device (LVAD), a mechanical pump that helps the heart work better.

To be eligible for this trial, participants must be at least 18 years old and have specific signs of heart failure and kidney issues. They should have been hospitalized for severe heart failure and may be potential candidates for an LVAD. Participants will receive daily SCD treatment for six days and will be followed closely for six months to monitor their health. This study aims to provide insights into whether this innovative treatment can be beneficial for patients who currently have limited options. If you or someone you know might be interested in this study, please discuss it with your healthcare provider.

Gender

ALL

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. 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.