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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:1 Randomization to Milrinone | Active Comparator | Milrinone will be given as a bolus dose of 50 mcg/kg. If a maintenance milrinone infusion is felt to be necessary, it will be maintained at 0.125-0.375 mcg/kg/min. |
|
| 1:1 No Intervention | No Intervention | Subjects without evidence of cardiogenic shock will not receive Milrinone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1:1 Randomization to receive milrinone | Drug | Randomized to receive either inotropic agent: milrinone or no agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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); | 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). | 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. | 2 years |
| Inotropes | Duration of time on inotropes during hospitalization | 2 years |
| Death | Cardiovascular death and/or all-cause mortality | 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), |
| Measure | Description | Time Frame |
|---|---|---|
| Durable support | Duration of time successfully off of counterpulsation, LVAD, or ECMO support | 6 hours |
| Durable support | Duration of time successfully off of counterpulsation, LVAD, or ECMO support |
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Inclusion Criteria:
LVEF ≤ 40%
Referred for RHC for:
Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
Age ≥ 18 years-old
Intent for admission based on RHC data
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Onsager, MD | Contact | 7737021000 | donsager1@uchgicagomedicine.org | |
| Daniel Rodgers | Contact | drodgers3@uchgicagomedicine.org |
| Name | Affiliation | Role |
|---|---|---|
| Valluvan Jeevanandam, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29754660 | Background | Hsu S, Thiruvengadam SK, Sciortino CM, Russell SD, Schulman SP. Predictors of intra-aortic balloon pump hemodynamic failure in non-acute myocardial infarction cardiogenic shock. Am Heart J. 2018 May;199:181-191. doi: 10.1016/j.ahj.2017.11.016. Epub 2017 Dec 13. | |
| 38547524 | Background | Zhang X, Wang Z, Zhang L, Zhao X, Han Y. Comparative Effectiveness and Safety of Intermittent, Repeated, or Continuous Use of Levosimendan, Milrinone, or Dobutamine in Patients With Advanced Heart Failure: A Network and Single-Arm Meta-analysis. J Cardiovasc Pharmacol. 2024 Jul 1;84(1):92-100. doi: 10.1097/FJC.0000000000001561. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D020105 | Milrinone |
| ID | Term |
|---|---|
| D000676 | Amrinone |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 |
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prospective, observational, crossover
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| 2 years |
| Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 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: Cardiac output by Fick (CO L/min/m2), Cardiac index by Fick (CI L/min/m2.) | 2 years |
| 12 hours |
| Durable support | Duration of time successfully off of counterpulsation, LVAD, or ECMO support | 24 hours |
| Durable support | Duration of time successfully off of counterpulsation, LVAD, or ECMO support | 36 hours |
| Durable support | Duration of time successfully off of counterpulsation, LVAD, or ECMO support | 48 hours |
| Durable support | Duration of time successfully off of counterpulsation, LVAD, or ECMO support | 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 | Up to 12 weeks |
| Home inotropic | Duration of time on home inotropic agents | 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) | 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:
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. | 2 years |
| 39601298 | Background | Gayatri D, Tongers J, Efremov L, Mikolajczyk R, Sedding D, Schumann J. Prophylactic use of inotropic agents for the prevention of low cardiac output syndrome and mortality in adults undergoing cardiac surgery. Cochrane Database Syst Rev. 2024 Nov 27;11(11):CD013781. doi: 10.1002/14651858.CD013781.pub2. |
| 15261929 | Result | Fincke R, Hochman JS, Lowe AM, Menon V, Slater JN, Webb JG, LeJemtel TH, Cotter G; SHOCK Investigators. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004 Jul 21;44(2):340-8. doi: 10.1016/j.jacc.2004.03.060. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |