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Heart FailureEarly Phase 1NCT05700617

Cardiac Power Output in Cardiogenic Shock Patients

A Early Phase 1 study testing 1:1 Randomization to receive milrinone in people with Heart Failure and Cardiogenic Shock, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiogenic Shock
What is being tested?
1:1 Randomization to receive milrinone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
6 Jul 2023to Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • LVEF ≤ 40%
  • Referred for RHC for:
  • 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
  • Assessment of cardiac function and valvular abnormalities prior to planned valvular surgery for MR or AI
Show all 9Show fewer
  • Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
  • Age ≥ 18 years-old
  • Intent for admission based on RHC data

Who cannot join

  • eGFR < 30 ml/min/1.73 m2
  • Severe, non-revascularized coronary artery disease
  • Concurrent acute coronary syndrome
  • Age < 18 years-old
  • History of significant ventricular arrhythmia without an ICD

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Onsager, MD contact

7737021000

donsager1@uchgicagomedicine.org

Daniel Rodgers contact

drodgers3@uchgicagomedicine.org

United States1 site, 1 recruiting

  • The University of Chicago

    Chicago, Illinois, 60637

    Carlisa Dixon, 773-834-4337, cdixon520@bsd.uchicago.edu

    Leila Yazdanbakhsh, 773-834-5087, leila.yazdanbakhsh@bsd.uchicago.edu

    Recruiting

Other trials in United States

About this study

Official title: Myocardial Reserve in Advanced Heart Failure Patients

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

Read the 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).

Being tested
1:1 Randomization to receive milrinone
Medical subject headings
Heart Failure, Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1:1 Randomization to receive milrinoneDrug

    Also called Milrinone

    Randomized to receive either inotropic agent: milrinone or no agent

Study groups in NCT05700617
Study groupRoleWhat they receive
1:1 Randomization to MilrinoneActive comparatorMilrinone 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.
Receives: Drug: 1:1 Randomization to receive milrinone
1:1 No InterventionNo interventionSubjects without evidence of cardiogenic shock will not receive Milrinone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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);

    Measured: 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).

    Measured: 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.

    Measured: 2 years

  4. Inotropes

    Duration of time on inotropes during hospitalization

    Measured: 2 years

  5. Death

    Cardiovascular death and/or all-cause mortality

    Measured: 2 years

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

    Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics 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),

    Measured: 2 years

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

    Efficacy of increasing cardiac output with milrinone compared to dobutamine using changes invasive hemodynamics 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.)

    Measured: 2 years

Secondary outcomes (10)

  1. Durable support

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

    Measured: 6 hours

  2. Durable support

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

    Measured: 12 hours

  3. Durable support

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

    Measured: 24 hours

  4. Durable support

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

    Measured: 36 hours

  5. Durable support

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

    Measured: 48 hours

  6. Durable support

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

    Measured: 72 hours

  7. Hospital discharge

    Hospital discharge without LVAD, OHT, home-inotropes, long-term counter-pulsation device (i.e NuPulse), or death.

    Patients will be monitored at the the following timepoints while admitted in the Cardiac Intensive Care Unit (CICU) 12 Hours 24 Hours 36 Hours 48 Hours 72 Hours

    Measured: Up to 12 weeks

  8. Home inotropic

    Duration of time on home inotropic agents

    Measured: 2 years

  9. LVAD decommissioning measuring mmHg

    If a patient is enrolled in the study that has an left ventricular assist device (LVAD) decommissioning or removal (not due to open heart transplant, pump malfunction, or death) the following will be assessed:

    1. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter:

    Pulmonary capillary wedge pressure (PCWP mmHg) Right Atrial pressure (RA mmHg) Pulmonary Atrial pressures (PA mmHg)

    Measured: 2 years

  10. LVAD decommissioning measuring L/min/m2

    If a patient is enrolled in the study that has an left ventricular assist device (LVAD) decommissioning or removal (not due to open heart transplant, pump malfunction, or death) the following will be assessed:

    1. Changes in invasive hemodynamics using a pulmonary artery (PA) catheter:
    2. Cardiac output by Fick (CO L/min/m2)
    3. Cardiac index by Fick (CI L/min/m2)
    4. Myocardial reserve (i.e. cardiac power output, aortic pulsatility index, Cardiac output by Fick (CO L/min/m2) Cardiac index by Fick (CI L/min/m2)) after inotrope challenge.
    5. Association of myocardial reserve with other known variables of cardiovascular and all-cause mortality.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start6 Jul 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
prospective, observational, crossover
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700617
Sponsor's protocol ID
IRB22-0817
Status last verified
Aug 2026
First submitted
1 Nov 2022
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hsu S, Thiruvengadam SK, Sciortino CM, Russell SD, Schulman SP. Predictors of intra-aortic balloon pump hemodynamic failure in non-acute myocardial infarction cardiogenic shock. Am Heart J. 2018 May;199:181-191. doi: 10.1016/j.ahj.2017.11.016. Epub 2017 Dec 13.

    PubMed 29754660

  • Zhang X, Wang Z, Zhang L, Zhao X, Han Y. Comparative Effectiveness and Safety of Intermittent, Repeated, or Continuous Use of Levosimendan, Milrinone, or Dobutamine in Patients With Advanced Heart Failure: A Network and Single-Arm Meta-analysis. J Cardiovasc Pharmacol. 2024 Jul 1;84(1):92-100. doi: 10.1097/FJC.0000000000001561.

    PubMed 38547524

  • Gayatri D, Tongers J, Efremov L, Mikolajczyk R, Sedding D, Schumann J. Prophylactic use of inotropic agents for the prevention of low cardiac output syndrome and mortality in adults undergoing cardiac surgery. Cochrane Database Syst Rev. 2024 Nov 27;11(11):CD013781. doi: 10.1002/14651858.CD013781.pub2.

    PubMed 39601298

  • Fincke R, Hochman JS, Lowe AM, Menon V, Slater JN, Webb JG, LeJemtel TH, Cotter G; SHOCK Investigators. Cardiac power is the strongest hemodynamic correlate of mortality in cardiogenic shock: a report from the SHOCK trial registry. J Am Coll Cardiol. 2004 Jul 21;44(2):340-8. doi: 10.1016/j.jacc.2004.03.060.

    PubMed 15261929

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 1:1 Randomization to receive milrinone in people with Heart Failure and Cardiogenic Shock, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Onsager, MD (7737021000, donsager1@uchgicagomedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05700617, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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