NCT05700617

Cardiac Power Output in Cardiogenic Shock Patients

Myocardial Reserve in Advanced Heart Failure Patients

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Heart Failure
• Cardiogenic Shock

Interventions

Type	Name	Description
DRUG	1:1 Randomization to receive milrinone	Randomized to receive either inotropic agent: milrinone or no agent

Timeline

• Start date: 2023-07-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-01-26
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study