Who is eligible for clinical trial NCT05485376?

Participants must meet protocol criteria for Cardiogenic Shock. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05485376 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-27

Pulmonary Artery Catheter in Cardiogenic Shock Trial (NCT05485376)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Tufts Medical Center

🩺 Plain-English Summary (8th-Grade Level)

The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (28 items).

Location: Tufts Medical Center — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥18 years and ≤90 years
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.
Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:
SBP \<90 mmHg for more than 30 minutes from baseline SBP
Requires the use of at least 1 vasopressor or inotrope
Requires intra-aortic balloon pump (IABP) support
Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam, dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominal swelling
Initial diagnosis of CS within 24 hours of screening at the enrolling site
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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.
Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment
Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)
Patient transferred from another facility with a diagnosis of cardiogenic shock
Any known co-morbidity other than heart failure with anticipated survival \< 6 months
Pre-enrollment labs (any of the following): International Normalized Ratio (INR) \> 3, Platelet count \< 50k, Hemoglobin \< 7
Refractory or recurrent cardiac arrest (\>1 episode requiring defibrillation or cardiopulmonary resuscitation) within 24 hours prior to screening
DNR/ DNI status
Pregnancy, child-birth within 6 months, or lactation
Active infection documented by persistent fever (Temp \> 38.4oC within 24 hours of screening) or confirmed bacteremia
Implantation of PPM or ICD within past 3 months

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Tufts Medical Center — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗