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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
DeviceImplantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: CardioMEMS Implant GroupExperimental treatment 1 intervention
Group B: Non-CardioMEMS Implant GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hierarchical primary endpoint
Hierarchical endpoint at 6-months, including death (or mortality-equivalent including left ventricular assist device implantation or heart transplantation), recurrent cardiovascular hospitalization, health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score, and change in log-transformed NT-proBNP level from enrollment to 6 months, evaluated by the win ratio according to the Finkelstein-Schoenfeld method
Time frame
6 monthsSecondary outcomes
1
Health related quality of life change from baseline
Health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score at 2 months and 6 months following admission for CS.hemodynamic monitor is safe in the high-risk CS population.
Time frame
2 months and 6 months2
All-cause mortality
All-cause mortality from enrollment.
Time frame
6 months3
All-cause mortality or cardiovascular hospitalization
Time to first all-cause mortality or cardiovascular hospitalization.
Time frame
6 months4
All-Cause Hospitalization
Time to all-cause hospitalization.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Inova Health Care Services
Lead sponsor
Abbott
Collaborator
Source ClinicalTrials.gov