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Cardiac Power Output in Cardiogenic Shock Patients
NCT05700617 · University of Chicago
In plain English
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Official title
Myocardial Reserve in Advanced Heart Failure Patients
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).
Eligibility criteria
Inclusion Criteria:
1. LVEF ≤ 40%
2. Referred for RHC for:
1. 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
2. Accurate assessment of invasive hemodynamics due to worsening clinical status, OR
3. Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR
4. Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI
3. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
4. Age ≥ 18 years-old
5. Intent for admission based on RHC data
Exclusion Criteria:
1. eGFR \< 30 ml/min/1.73 m2
2. Severe, non-revascularized coronary artery disease
3. Concurrent acute coronary syndrome
4. Age \< 18 years-old
5. History of significant ventricular arrhythmia without an ICD
Study design
Enrollment target: 5 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-06
Estimated completion: 2026-06
Last updated: 2025-07-08
Interventions
Drug: 1:1 Randomization to receive milrinone
Primary outcomes
- • Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring 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 (Baseline and 6,12,24,36,72 Hours post-inotrope challenge.)
- • Advanced heart failure therapy (2 years)
Sponsor
University of Chicago · other
Contacts & investigators
ContactDavid Onsager, MD · contact · donsager1@uchgicagomedicine.org · 7737021000
ContactDaniel Rodgers · contact · drodgers3@uchgicagomedicine.org
InvestigatorValluvan Jeevanandam, MD · principal_investigator, University of Chicago
All locations (1)
The University of ChicagoRecruiting
Chicago, Illinois, United States