The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.
This study is designed as a prospective, observational, crossover study to assess the feasibility of using differences in invasive hemodynamics of cardiac function, representing myocardial reserve, to predict clinical outcomes for heart failure patients. Patients with heart failure referred for right heart catheterization (RHC) by the advanced heart failure team as part of 1) evaluation for advanced heart failure therapies, including left ventricular assist device (LVAD), orthotopic heart transplant (OHT), temporary or long-term inotrope therapy, or counter-pulsation (temporary intra-aortic balloon pump (IABP) or long-term with NuPulse device), 2) for accurate assessment of invasive hemodynamics due to worsening clinical status, 3) assessment of myocardial recovery for consideration of LVAD or NuPulse decommissioning or removal or mechanical circulatory support removal, or 4) accurate assessment of cardiac function in patients with reduced LVEF prior to valve replacement for aortic insufficiency (AI) or mitral regurgitation (MR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Randomized to receive either inotropic agent: milrinone or no agent
The University of Chicago
Chicago, Illinois, United States
RECRUITINGChanges in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg
Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg); Right Atrial pressure (RA mmHg); Pulmonary Atrial pressures (PA mmHg);
Time frame: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring L/min/m2
Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2); Cardiac index by Fick (CI L/min/m2).
Time frame: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
Advanced heart failure therapy
Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death.
Time frame: 2 years
Inotropes
Duration of time on inotropes during hospitalization
Time frame: 2 years
Death
Cardiovascular death and/or all-cause mortality
Time frame: 2 years
Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years
Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg), Right Atrial pressure (RA mmHg), Pulmonary Atrial pressures (PA mmHg),
Time frame: 2 years
Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years
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Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2), Cardiac index by Fick (CI L/min/m2.)
Time frame: 2 years
Durable support
Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Time frame: 6 hours
Durable support
Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Time frame: 12 hours
Durable support
Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Time frame: 24 hours
Durable support
Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Time frame: 36 hours
Durable support
Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Time frame: 48 hours
Durable support
Duration of time successfully off of counterpulsation, LVAD, or ECMO support
Time frame: 72 hours
Hospital discharge
Hospital discharge without LVAD, OHT, home-inotropes, long-term counter-pulsation device (i.e NuPulse), or death. Patients will be monitored at the the following timepoints while admitted in the Cardiac Intensive Care Unit (CICU) 12 Hours 24 Hours 36 Hours 48 Hours 72 Hours
Time frame: Up to 12 weeks
Home inotropic
Duration of time on home inotropic agents
Time frame: 2 years
LVAD decommissioning measuring mmHg
If a patient is enrolled in the study that has an left ventricular assist device (LVAD) decommissioning or removal (not due to open heart transplant, pump malfunction, or death) the following will be assessed: A. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg) Right Atrial pressure (RA mmHg) Pulmonary Atrial pressures (PA mmHg)
Time frame: 2 years
LVAD decommissioning measuring L/min/m2
If a patient is enrolled in the study that has an left ventricular assist device (LVAD) decommissioning or removal (not due to open heart transplant, pump malfunction, or death) the following will be assessed: A. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter: 1. Cardiac output by Fick (CO L/min/m2) 2. Cardiac index by Fick (CI L/min/m2) B. Myocardial reserve (i.e. cardiac power output, aortic pulsatility index, Cardiac output by Fick (CO L/min/m2) Cardiac index by Fick (CI L/min/m2)) after inotrope challenge. C. Association of myocardial reserve with other known variables of cardiovascular and all-cause mortality.
Time frame: 2 years