Cardiac Power Output in Cardiogenic Shock Patients

NCT05700617 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB22-0817
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Cardiogenic Shock

Outcome Measures

Primary Outcomes (7)

• 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),

  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

Secondary Outcomes (10)

• Durable support

  6 hours

• Durable support

  12 hours

• Durable support

  24 hours

• Durable support

  36 hours

• Durable support

  48 hours

Study Arms (2)

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.

Drug: 1:1 Randomization to receive milrinone

1:1 No Intervention

NO INTERVENTION

Subjects without evidence of cardiogenic shock will not receive Milrinone.

Interventions

1:1 Randomization to receive milrinone DRUG

Randomized to receive either inotropic agent: milrinone or no agent

Also known as: Milrinone

1:1 Randomization to Milrinone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 29754660 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.

  PMID: 38547524 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.

  PMID: 39601298 BACKGROUND

• 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.

  PMID: 15261929 RESULT

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic

Interventions

Milrinone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amrinone; Aminopyridines; Amines; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Valluvan Jeevanandam, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Onsager, MD

CONTACT

7737021000; donsager1@uchgicagomedicine.org

Daniel Rodgers

CONTACT

drodgers3@uchgicagomedicine.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, observational, crossover

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: January 26, 2023
• Study Start: July 6, 2023
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)