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Led by University of Chicago · Updated on 2026-08-06
5
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating whether differences in heart muscle reserve, measured through invasive heart function tests, can predict outcomes in patients with heart failure. This observational, crossover study focuses on patients referred for right heart catheterization due to advanced heart failure evaluation, worsening symptoms, myocardial recovery assessment, or pre-surgical evaluation for valve issues. Participants may be randomly assigned to receive milrinone, an inotropic drug given as a bolus dose with possible maintenance infusion, or no intervention if they show no signs of cardiogenic shock. The study uses pulmonary artery catheters to monitor heart function at multiple time points after treatment, with follow-up extending up to two years to assess therapy needs, heart function changes, and survival. During the study, participants undergo invasive hemodynamic monitoring via pulmonary artery catheters at baseline and several intervals post-treatment. Researchers will track heart function, advanced therapies, inotrope use, and survival over two years, along with hospital discharge and device decommissioning outcomes. This comprehensive monitoring aims to evaluate myocardial reserves role in predicting clinical outcomes for heart failure patients.
CONDITIONS
Cardiac Power Output in Cardiogenic Shock Patients
D
David Onsager, MD
D
Daniel Rodgers
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University of Chicago
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Milrinone | No Inotrope Condition |
|---|---|---|
| What it is | An intravenous phosphodiesterase‑III inotrope (milrinone) administered during the crossover period. | No inotropic agent administered during the crossover period as the comparator condition. |
| Role in trial | Serves as the investigational active condition to assess hemodynamic response. | Serves as the baseline or control condition to measure changes compared to milrinone. |
| Primary use or measurement focus | To improve invasive hemodynamics during right heart catheterization after inotropic challenge. | To provide baseline invasive hemodynamic measurements during right heart catheterization without inotrope. |
| How it is given or performed | Intravenous inotrope administration during catheter‑measured hemodynamic assessment. | No inotropic administration during catheter‑measured hemodynamic assessment. |
| Evidence status | Limited high‑quality data comparing milrinone to no inotrope in cardiogenic shock; milrinone and dobutamine show similar outcomes in randomized trials. | Baseline hemodynamic condition without inotrope use serves as essential reference, but lacks broader outcome evidence in isolation. |
| Important risks | Milrinone may cause hypotension, arrhythmias, and is renally cleared, requiring caution in low kidney function. | Without inotrope, hemodynamic compromise may persist, risking organ hypoperfusion in cardiogenic shock. |
| Important limitations | Findings may not generalize due to small sample size (n=5), early‑phase design, and short‑term hemodynamic focus rather than long‑term outcomes. | Using no inotrope as comparator may reflect only immediate baseline but does not evaluate active standard care involving alternative inotropes. |
| Patient‑relevant outcomes | No direct evidence yet that milrinone improves long‑term clinical outcomes such as mortality or transition to advanced therapies. | Baseline condition provides reference for treatment effect, but offers no direct long‑term benefit without therapeutic intervention. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 hours post-inotrope challenge
Participants are randomly assigned to receive milrinone infusion or no intervention depending on signs of cardiogenic shock. Heart function is monitored using invasive pulmonary artery catheter measurements.
Multiple monitoring timepoints at baseline, 6, 12, 24, 36, and 72 hours
Duration - Up to 2 years
Participants are followed for up to 2 years to monitor advanced heart failure therapies, inotrope use, heart function, and survival outcomes.
Periodic assessments during follow-up
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
