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Beta-1 Adrenergic Receptor Agonist

Milrinone vs Dobutamine for Cardiogenic Shock

Phase < 1

Recruiting

Led By Valluvan Jeevanandam, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

LVEF ≤ 35%

Referred for RHC for assessment of myocardial recovery for consideration of LVAD or counter-pulsation decommissioning or removal

Must not have

eGFR < 30 ml/min/1.73 m2

Severe, non-revascularized coronary artery disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if differences in heart muscle function can help predict outcomes in patients with heart failure."

Who is the study for?

This trial is for adults over 18 with severe heart failure (LVEF ≤ 35%) who are being evaluated for advanced treatments like LVAD, heart transplants, or other therapies. They must have a kidney function above a certain level (eGFR ≥ 30 ml/min/1.73 m2) and be hospitalized based on specific heart health measurements.

What is being tested?

The study aims to see if milrinone or dobutamine better improves cardiac power output in patients with cardiogenic shock. Patients will be randomly assigned to receive either drug in equal numbers to compare their effects on the heart's pumping ability.

What are the potential side effects?

Both milrinone and dobutamine can cause irregular heartbeat, blood pressure changes, headaches, nausea, and increased risk of arrhythmias. The severity of side effects may vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is significantly reduced.

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I am being evaluated for heart function recovery to possibly remove or adjust my heart support device.

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I am 18 years old or older.

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I am being considered for advanced heart failure treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced.

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I have severe heart artery blockage that hasn't been treated with surgery.

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I am under 18 years old.

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I am currently experiencing a heart attack or related symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Advanced heart failure therapy

Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years

Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years

+4 more

Secondary study objectives

Durable support

Home inotropic

Hospital discharge

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: 1:1 Randomization to Dobutamine or MilrinoneActive Control1 Intervention

Patients will be randomized 1:1 to either Milrinone or Dobutamine. Dobutamine will be infused at 10-40 mcg/kg/min during the infusion phase, and for those randomized to dobutamine for maintenance, they will be kept at 5-10 mcg/kg/min. Milrinone will be given as a bolus at a dose of 5 mcg/kg/min over 15 minutes, for a total of 75 mcg/kg. For patients randomized to the arm for maintenance milrinone, they will be maintained at 0.125-0.375 mcg/kg/min.

Group II: 1:1 Randomization to Milrinone or DobutamineActive Control1 Intervention

Patients will be randomized 1:1 to either Milrinone or Dobutamine. Milrinone will be given as a bolus at a dose of 5 mcg/kg/min over 15 minutes, for a total of 75 mcg/kg. For patients randomized to the arm for maintenance milrinone, they will be maintained at 0.125-0.375 mcg/kg/min. Patients may be randomized to dobutamine will be infused at 10-40 mcg/kg/min during the infusion phase and for those randomized to dobutamine for maintenance, they will be kept at 5-10 mcg/kg/min.

0 / 8Eligibility criteria met