Pulmonary Artery Catheter in Cardiogenic Shock Trial

Eligibility Criteria

• 1. Age ≥18 years and ≤90 years
• 2. Clinical heart failure presentation and left ventricular function as follows: Either 2A or 2B must be present A. Subject has de novo acute decompensated heart failure and shock with an LVEF ≤40% OR B. Subject has acute on chronic heart failure with a documented history of a LVEF ≤40% within 6 months of admission and a current LVEF ≤40% within 24 hours of screening during the current hospitalization.
• 3. Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:
• 1. SBP \<90 mmHg for more than 30 minutes from baseline SBP
• 2. Requires the use of at least 1 vasopressor or inotrope
• 3. Requires intra-aortic balloon pump (IABP) support
• 4. Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam, dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominal swelling
• 4. Initial diagnosis of CS within 24 hours of screening at the enrolling site
• 5. Patient or legally authorized representative provides informed consent
• 1. Primary etiology of shock other than systolic left heart failure including but not limited to: acute myocardial infarction, sepsis, hypovolemia, hemorrhage, severe anemia, primary RV failure, pulmonary embolism, or tamponade.
• 2. Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment
• 3. Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)
• 4. Patient transferred from another facility with a diagnosis of cardiogenic shock
• 5. Any known co-morbidity other than heart failure with anticipated survival \< 6 months
• 6. Pre-enrollment labs (any of the following): International Normalized Ratio (INR) \> 3, Platelet count \< 50k, Hemoglobin \< 7
• 7. Refractory or recurrent cardiac arrest (\>1 episode requiring defibrillation or cardiopulmonary resuscitation) within 24 hours prior to screening
• 8. DNR/ DNI status
• 9. Pregnancy, child-birth within 6 months, or lactation
• 10. Active infection documented by persistent fever (Temp \> 38.4oC within 24 hours of screening) or confirmed bacteremia
• 11. Implantation of PPM or ICD within past 3 months
• 12. Mechanical complication of AMI (ie VSD, papillary muscle rupture, flail mitral regurgitation, free wall rupture)
• 13. Anoxic brain injury
• 14. On renal replacement therapy prior to enrollment
• 15. Cardiac surgery within 3 months of current admission
• 16. Severe aortic, pulmonic, tricuspid stenosis or acute structural mitral regurgitation or infective endocarditis
• 17. History of cardiac amyloid
• 18. Congenital heart disease excluding the presence of a bicuspid aortic valve
• 19. Planned cardiac surgery during admission
• 20. World Health Organization (WHO) Group I, III, IV, or V pulmonary hypertension
• 21. Any known contraindication to PAC placement
• 22. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
• 23. Any medical or psychiatric condition such as dementia, alcoholism, or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up
• 24. Prior stroke with any permanent neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
• 25. Subject has previously hospitalized for COVID-19 unless he/she has been discharged and asymptomatic for ≥4 weeks
• 26. Subject is COVID-19 PCR/antigen positive within the prior 4 weeks
• 27. Subject belongs to a vulnerable population \[defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, members of the armed forces and persons kept in detention\]