Recruiting
Early Phase 1

Cardiac Power Output

Sponsor:

University of Chicago

Code:

NCT05700617

Conditions

Heart Failure

Cardiogenic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

1:1 Randomization to receive milrinone

Study Details

Brief summary:

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

Study ID

NCT05700617

Start date

Jul 6, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

5 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

1:1 Randomization to receive milrinone

Randomized to receive either inotropic agent: milrinone or no agent

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

More Information

Sponsor

University of Chicago

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-08-06.