Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Conditions:
🦠 Cardiogenic Shock 🦠 Heart Failure 🦠 Ambulatory Hemodynamic Monitoring
🗓️ Study Start (Actual) 31 December 2020
🗓️ Primary Completion (Estimated) 31 December 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Falls Church, Virginia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
    • 2. Age ≥ 18 years
    • 3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
    • 4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \< 90 mmHg for \> 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \< 30 mL/h, or serum lactate \> 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.
    • 5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).

    Exclusion Criteria:

    • 1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
    • 2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
    • 3. If of childbearing potential with a positive pregnancy test.
    • 4. Transition to hospice care.
    • 5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
    • 6. Presence of an active, uncontrolled infection.
    • 7. Any condition other than heart failure that could limit survival to less than 6 months
    • 8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.
    • 9. No access to internet or phone.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 June 2020
  • First Submitted that Met QC Criteria 3 June 2020
  • First Posted 5 June 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 February 2024
  • Last Update Posted 13 February 2024
  • Last Verified February 2024