Cardiac Power Output in Cardiogenic Shock Patients

Heart Failure Clinical Trial

Official title:

Myocardial Reserve in Advanced Heart Failure Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05700617
• Other study ID #: IRB22-0817
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Chicago
• Contact: David Onsager, MD
• Phone: 7737021000
• Email: donsager1[@]uchgicagomedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. LVEF = 35%

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

Related Conditions & MeSH terms

• Cardiogenic Shock
• Heart Failure
• Shock, Cardiogenic

Intervention

Drug:
• 1:1 Randomization to receive milrinone or dobutamine
Randomized to receive either inotropic agent: milrinone or dobutamine
• 1:1 Randomization to receive dobutamine or milrinone
Randomized to receive either inotropic agent: milrinone or dobutamine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

References & Publications (2)

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 — View Citation

Hsu S, Kambhampati S, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Advanced heart failure therapy	Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death.	2 years
Primary	Inotropes	Duration of time on inotropes during hospitalization	2 years
Primary	Death	Cardiovascular death and/or all-cause mortality	2 years
Primary	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),	2 years
Primary	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
Secondary	Durable support	Duration of time successfully off of counterpulsation, LVAD, or ECMO support	6 hours
Secondary	Durable support	Duration of time successfully off of counterpulsation, LVAD, or ECMO support	12 hours
Secondary	Durable support	Duration of time successfully off of counterpulsation, LVAD, or ECMO support	24 hours
Secondary	Durable support	Duration of time successfully off of counterpulsation, LVAD, or ECMO support	36 hours
Secondary	Durable support	Duration of time successfully off of counterpulsation, LVAD, or ECMO support	48 hours
Secondary	Durable support	Duration of time successfully off of counterpulsation, LVAD, or ECMO support	72 hours
Secondary	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
Secondary	Home inotropic	Duration of time on home inotropic agents	2 years
Secondary	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
Secondary	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: Cardiac output by Fick (CO L/min/m2); 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.	2 years