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NCT Number: NCT05700617

Cardiac Power Output in Cardiogenic Shock Patients

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

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Key information

Conditions

Heart Failure Cardiogenic Shock Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • LVEF ≤ 40%
  • Referred for RHC for:
  • 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
  • Accurate assessment of invasive hemodynamics due to worsening clinical status, OR
  • Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR
  • Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI
  • Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
  • Age ≥ 18 years-old
  • Intent for admission based on RHC data

Exclusion criteria

  • eGFR < 30 ml/min/1.73 m2
  • Severe, non-revascularized coronary artery disease
  • Concurrent acute coronary syndrome
  • Age < 18 years-old
  • History of significant ventricular arrhythmia without an ICD

Treatment and study plan

1:1 Randomization to receive milrinone

Drug

Randomized to receive either inotropic agent: milrinone or no agent

Other names: Milrinone

Primary outcomes

  1. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg

    Time frame: 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);

  2. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring L/min/m2

    Time frame: 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).

  3. Advanced heart failure therapy

    Time frame: 2 years

    Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death.

  4. Inotropes

    Time frame: 2 years

    Duration of time on inotropes during hospitalization

  5. Death

    Time frame: 2 years

    Cardiovascular death and/or all-cause mortality

  6. Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years

    Time frame: 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),

  7. Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years

    Time frame: 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 outcomes

  1. Durable support

    Time frame: 6 hours

    Duration of time successfully off of counterpulsation, LVAD, or ECMO support

  2. Durable support

    Time frame: 12 hours

    Duration of time successfully off of counterpulsation, LVAD, or ECMO support

  3. Durable support

    Time frame: 24 hours

    Duration of time successfully off of counterpulsation, LVAD, or ECMO support

  4. Durable support

    Time frame: 36 hours

    Duration of time successfully off of counterpulsation, LVAD, or ECMO support

  5. Durable support

    Time frame: 48 hours

    Duration of time successfully off of counterpulsation, LVAD, or ECMO support

  6. Durable support

    Time frame: 72 hours

    Duration of time successfully off of counterpulsation, LVAD, or ECMO support

  7. Hospital discharge

    Time frame: 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

  8. Home inotropic

    Time frame: 2 years

    Duration of time on home inotropic agents

  9. LVAD decommissioning measuring mmHg

    Time frame: 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)

  10. LVAD decommissioning measuring L/min/m2

    Time frame: 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:

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Rodgers

CONTACT

[email protected]

David Onsager, MD

CONTACT

[email protected]

7737021000

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Myocardial Reserve in Advanced Heart Failure Patients

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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