Cardiac Power Output in Cardiogenic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-06

Study Completion Date

2026-06-30

Brief Summary

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The main purpose of this study is to determine whether differences in myocardial reserve predict clinical outcomes for heart failure patients.

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Detailed Description

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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

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Heart Failure Cardiogenic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

prospective, observational, crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

1:1 Randomization to receive milrinone

Intervention Type DRUG

Randomized to receive either inotropic agent: milrinone or no agent

1:1 No Intervention

Subjects without evidence of cardiogenic shock will not receive Milrinone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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1:1 Randomization to receive milrinone

Randomized to receive either inotropic agent: milrinone or no agent

Intervention Type DRUG

Other Intervention Names

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Milrinone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No