Cardiac Power Output in Cardiogenic Shock Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 1:1 Randomization to receive milrinone.
- Who it may be relevant to
- Registry conditions: Heart Failure, Cardiogenic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Myocardial Reserve in Advanced Heart Failure Patients
Overview
The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.
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).
Interventions
- Drug 1:1 Randomization to receive milrinone
Randomized to receive either inotropic agent: milrinone or no agent
Primary outcome measures
- Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg [Time frame: 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 [Time frame: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.]
- Advanced heart failure therapy [Time frame: 2 years]
- Inotropes [Time frame: 2 years]
- Death [Time frame: 2 years]
- Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years [Time frame: 2 years]
- Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years [Time frame: 2 years]
Secondary outcome measures (10)
- Durable support [Time frame: 6 hours]
- Durable support [Time frame: 12 hours]
- Durable support [Time frame: 24 hours]
- Durable support [Time frame: 36 hours]
- Durable support [Time frame: 48 hours]
- Durable support [Time frame: 72 hours]
- Hospital discharge [Time frame: Up to 12 weeks]
- Home inotropic [Time frame: 2 years]
- LVAD decommissioning measuring mmHg [Time frame: 2 years]
- LVAD decommissioning measuring L/min/m2 [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- LVEF ≤ 40%
- Referred for RHC for:
- 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
- Accurate assessment of invasive hemodynamics due to worsening clinical status, OR
- Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR
- Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI
- Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
- Age ≥ 18 years-old
- Intent for admission based on RHC data
Exclusion criteria
- eGFR < 30 ml/min/1.73 m2
- Severe, non-revascularized coronary artery disease
- Concurrent acute coronary syndrome
- Age < 18 years-old
- History of significant ventricular arrhythmia without an ICD
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Chicago — Chicago
Publications
- Hsu S, Thiruvengadam SK, Sciortino CM, Russell SD, Schulman SP. Predictors of intra-aortic balloon pump hemodynamic failure in non-acute myocardial infarction cardiogenic shock. Am Heart J. 2018 May;199:181-191. doi: 10.1016/j.ahj.2017.11.016. Epub 2017 Dec 13. PMID 29754660
- Zhang X, Wang Z, Zhang L, Zhao X, Han Y. 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. J Cardiovasc Pharmacol. 2024 Jul 1;84(1):92-100. doi: 10.1097/FJC.0000000000001561. PMID 38547524
- Gayatri D, Tongers J, Efremov L, Mikolajczyk R, Sedding D, Schumann J. Prophylactic use of inotropic agents for the prevention of low cardiac output syndrome and mortality in adults undergoing cardiac surgery. Cochrane Database Syst Rev. 2024 Nov 27;11(11):CD013781. doi: 10.1002/14651858.CD013781.pub2. PMID 39601298
- Fincke R, Hochman JS, Lowe AM, Menon V, Slater JN, Webb JG, LeJemtel TH, Cotter G; SHOCK Investigators. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004 Jul 21;44(2):340-8. doi: 10.1016/j.jacc.2004.03.060. PMID 15261929
Identifiers
NCT: NCT05700617 · IRB22-0817