Cardiogenic Shock, Heart Failure
Conditions
Brief summary
The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.
Detailed description
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).
Interventions
DRUG1:1 Randomization to receive milrinone
Randomized to receive either inotropic agent: milrinone or no agent
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, observational, crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. LVEF ≤ 40% 2. Referred for RHC for: 1. Evaluation for advanced heart failure therapies, including LVAD, OHT, temporary or long-term inotrope therapy, or counter-pulsation (temporary or long-term with NuPulse device OR 2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR 3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR 4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI 3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2 4. Age ≥ 18 years-old 5. Intent for admission based on RHC data
Exclusion criteria
1. eGFR \< 30 ml/min/1.73 m2 2. Severe, non-revascularized coronary artery disease 3. Concurrent acute coronary syndrome 4. Age \< 18 years-old 5. History of significant ventricular arrhythmia without an ICD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg | Baseline and 6,12,24,36,72 Hours post-inotrope challenge. | 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); |
| Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring L/min/m2 | Baseline and 6,12,24,36,72 Hours post-inotrope challenge. | 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). |
| Advanced heart failure therapy | 2 years | Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death. |
| Inotropes | 2 years | Duration of time on inotropes during hospitalization |
| Death | 2 years | Cardiovascular death and/or all-cause mortality |
| Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years | 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), |
| Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years | 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: Cardiac output by Fick (CO L/min/m2), Cardiac index by Fick (CI L/min/m2.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durable support | 6 hours | Duration of time successfully off of counterpulsation, LVAD, or ECMO support |
| Hospital discharge | Up to 12 weeks | 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 |
| Home inotropic | 2 years | Duration of time on home inotropic agents |
| LVAD decommissioning measuring mmHg | 2 years | 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) |
| LVAD decommissioning measuring L/min/m2 | 2 years | 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. |
Countries
United States
Contacts
CONTACTDavid Onsager, MD
CONTACTDaniel Rodgers
PRINCIPAL_INVESTIGATORValluvan Jeevanandam, MD
University of Chicago
Outcome results
None listed