Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Implantation 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.
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
RECRUITINGHierarchical 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 months
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 months
All-cause mortality
All-cause mortality from enrollment.
Time frame: 6 months
All-cause mortality or cardiovascular hospitalization
Time to first all-cause mortality or cardiovascular hospitalization.
Time frame: 6 months
All-Cause Hospitalization
Time to all-cause hospitalization.
Time frame: 6 months
Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Time frame: 6 months
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Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.
Time frame: 6 months
Achieved guideline directed medical therapy for heart failure
Achieved guideline directed medical therapy for heart failure with reduced ejection fraction at 6 months, measured by achievement of \>50% of the guideline targeted optimal dosing of angiotensin receptor blocker or angiotensin converting enzyme inhibitor or angiotensin receptor neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist.
Time frame: 6 months
Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.
Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitor in the high-risk CS population, including device-related or system-related complications or pressure-sensor failures.
Time frame: 6 months