NCT05700617EARLY_PHASE1Recruiting

Cardiac Power Output in Cardiogenic Shock Patients

University of Chicago

Start Date

7/6/2023

Completion Date

6/1/2026

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

1:1 Randomization to receive milrinone

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Conditions

Heart FailureCardiogenic Shock

Locations

The University of Chicago

Chicago, Illinois 60637

United States