Cardiac Power Output in Cardiogenic Shock Patients
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- prospective, observational, crossover
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 1:1 Randomization to Milrinone |
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. |
|
|
No Intervention 1:1 No Intervention |
Subjects without evidence of cardiogenic shock will not receive Milrinone. |
|
Recruiting Locations
Chicago, Illinois 60637
More Details
- Status
- Recruiting
- Sponsor
- University of Chicago
Detailed Description
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).