Health TrialsbyHealthPanel

Cardiac Power Output in Cardiogenic Shock Patients

ConditionsHeart FailureCardiogenic Shock
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

LVEF ≤ 40%

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

Accurate assessment of invasive hemodynamics due to worsening clinical status, OR

Assessment of myocardial recovery for consideration of LVAD or counter-pulsation (temporary IABP or long-term with NuPulse device) decommissioning or removal OR

Disqualifiers

eGFR < 30 ml/min/1.73 m2

Severe, non-revascularized coronary artery disease

Concurrent acute coronary syndrome

Age < 18 years-old

Trial design

Design model

Crossover

Treatments tested in this trial

  • 1:1 Randomization to receive milrinone

    Drug

    Randomized to receive either inotropic agent: milrinone or no agent

Treatment groups

5 Participants
are divided into 2 treatment groups
Group A: 1:1 Randomization to MilrinoneActive comparator 1 intervention
Group B: 1:1 No InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg

Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Pulmonary capillary wedge pressure (PCWP mmHg); Right Atrial pressure (RA mmHg); Pulmonary Atrial pressures (PA mmHg);

Time frame
Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
2

Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring L/min/m2

Changes invasive hemodynamics representing myocardial reserve will be measured in 5 patients using a pulmonary artery (PA) catheter: Cardiac output by Fick (CO L/min/m2); Cardiac index by Fick (CI L/min/m2).

Time frame
Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
3

Advanced heart failure therapy

Duration of time without need for definitive advanced heart failure therapy (LVAD, OHT) or death.

Time frame
2 years
4

Inotropes

Duration of time on inotropes during hospitalization

Time frame
2 years

Secondary outcomes

1

Durable support

Duration of time successfully off of counterpulsation, LVAD, or ECMO support

Time frame
6 hours
2

Durable support

Duration of time successfully off of counterpulsation, LVAD, or ECMO support

Time frame
12 hours
3

Durable support

Duration of time successfully off of counterpulsation, LVAD, or ECMO support

Time frame
24 hours
4

Durable support

Duration of time successfully off of counterpulsation, LVAD, or ECMO support

Time frame
36 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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