Status:
NOT_YET_RECRUITING
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Lead Sponsor:
SeaStar Medical
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Conditions:
Acute on Chronic Systolic Congestive Heart Failure
Cardiorenal Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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.
- Optimal intravenous diuretic therapy is defined as:
- Furosemide equivalent total daily dose of 240mg
- Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion
- A furosemide equivalent total daily dose \<240mg if the dose has resulted in \>3000 mL urine output/24 hours.
- PA catheter in place at the time of enrollment
- PCW ≥ 20 mmHg
- eGFR calculated using the CKD-EPI Creatinine Equation \*\*\* Recognizing that this is not a steady state creatinine
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03836482
Start Date
September 30 2025
End Date
August 1 2027
Last Update
September 18 2025
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