Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services

About this trial

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock

Eligibility criteria

Qualifiers

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.

Age ≥ 18 years

NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).

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.

Disqualifiers

Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.

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.

If of childbearing potential with a positive pregnancy test.

Transition to hospice care.

Trial design

Treatments tested in this trial

  • CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators