Using a Pulmonary Artery Catheter to Improve Outcomes in Cardiogenic Shock

The Pulmonary Artery Catheter in Cardiogenic Shock Trial

This study is testing if using a special heart monitoring device early on can help people with severe heart failure feel better and survive their hospital stay.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Tufts Medical Center (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT05485376 on ClinicalTrials.gov

What this trial studies

The PACCS trial aims to determine if early invasive hemodynamic assessment and management using a pulmonary artery catheter (PAC) can reduce in-hospital mortality in patients experiencing cardiogenic shock due to acutely decompensated heart failure. This multicenter, randomized trial will compare outcomes between patients receiving immediate PAC assessment and those receiving standard care with delayed or no PAC assessment. The study will adaptively adjust its sample size based on interim analyses, starting with a minimum of 400 participants and potentially increasing to 800.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 90 with acute decompensated heart failure and cardiogenic shock, characterized by specific left ventricular function and lactate levels.

Not a fit: Patients with stable heart failure or those not meeting the criteria for cardiogenic shock may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the risk of in-hospital mortality for patients with cardiogenic shock.

How similar studies have performed: Previous studies have shown promising results with early hemodynamic monitoring in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion 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.

   NOTE: The LVEF must be quantitatively measured as ≤ 40% by an echocardiogram within 24 hours of screening. If multiple echocardiograms have been performed within 24 hours, the most recent test must be used to qualify the patient.
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

A HIPAA waiver for screening is requested to identify potential subjects. No recruitment materials will be given to potential subjects. No identifiable data will be retained for subjects that are determined to be ineligible

Exclusion Criteria:

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 \[defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, members of the armed forces and persons kept in detention\]

Where this trial is running

Boston, Massachusetts

• Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Navin K Kapur, MD — [e-mail]
• Study coordinator: Karol Walec

Conditions Cardiogenic Shock; Heart Failure; Pulmonary Artery Catheter