Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID05700617

Myocardial Reserve in Advanced Heart Failure Patients Evaluated by Right Heart Catheterization with Milrinone Inotrope Challenge

Led by University of Chicago · Updated on 2025-07-08

5

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether differences in myocardial reserve, measured by invasive hemodynamics, can predict clinical outcomes in patients with heart failure. This prospective, observational, crossover study focuses on patients undergoing right heart catheterization (RHC) for advanced heart failure evaluation or worsening clinical status. It includes patients considered for advanced therapies such as left ventricular assist device (LVAD), heart transplant, inotrope therapy, or counter-pulsation devices, as well as those assessed before valve surgery for aortic insufficiency or mitral regurgitation. Participants are randomized into two groups: one receives an inotropic agent called milrinone, given as a bolus dose of 50 mcg/kg followed by a maintenance infusion if needed, and the other group does not receive milrinone. Those without cardiogenic shock will not receive milrinone. The study involves monitoring invasive hemodynamic changes using a pulmonary artery catheter at baseline and several time points up to 72 hours after the inotrope challenge. During the study, patients undergo repeated cardiac output measurements and invasive hemodynamic assessments. Researchers track advanced heart failure therapies, inotrope use, hospital discharge, and survival over a two-year period. Secondary outcomes include duration on durable support and LVAD decommissioning measures. The total follow-up includes monitoring up to two years to assess long-term clinical outcomes related to myocardial reserve.

CONDITIONS

Brief Title

Cardiac Power Output in Cardiogenic Shock Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Left ventricular ejection fraction (LVEF) of 40% or less
  • Referred for right heart catheterization (RHC) for advanced heart failure evaluation, worsening clinical status, myocardial recovery assessment, or pre-valve surgery assessment
  • Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
  • Age 18 years or older
  • Intent for hospital admission based on RHC data
Not Eligible

You will not qualify if you...

  • Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2
  • Severe, untreated coronary artery disease
  • Current acute coronary syndrome
  • Age younger than 18 years
  • History of significant ventricular arrhythmia without an implantable cardioverter defibrillator (ICD)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 72 hours

Participants undergo right heart catheterization and are randomized to receive milrinone inotrope challenge or no intervention to assess cardiac function.

1 hospitalization period with continuous monitoring

Follow-up

Duration - 2 years

Participants are monitored for clinical outcomes including advanced heart failure therapy, inotrope use, and survival over 2 years after treatment.

Periodic assessments during follow-up

Trial Site Locations

Total: 1 location

1

The University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

D

David Onsager, MD

D

Daniel Rodgers

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Predictors of intra-aortic balloon pump hemodynamic failure in non-acute myocardial infarction cardiogenic shock.

Steven Hsu, Swetha Kambhampati Thiruvengadam, Christopher M Sciortino...

https://pubmed.ncbi.nlm.nih.gov/29754660

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.

Xue Zhang, Zhongsu Wang, Le Zhang...

https://pubmed.ncbi.nlm.nih.gov/38547524

Prophylactic use of inotropic agents for the prevention of low cardiac output syndrome and mortality in adults undergoing cardiac surgery.

Dwi Gayatri, Jörn Tongers, Ljupcho Efremov...

https://pubmed.ncbi.nlm.nih.gov/39601298

Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry.

Rupert Fincke, Judith S Hochman, April M Lowe...

https://pubmed.ncbi.nlm.nih.gov/15261929