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/29754660Actively Recruiting
Led by University of Chicago · Updated on 2025-07-08
5
Participants Needed
1
Research Sites
N/A
Total Duration
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
Cardiac Power Output in Cardiogenic Shock Patients
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
D
David Onsager, MD
D
Daniel Rodgers
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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