RecruitingEarly Phase 1

Cardiac Power Output in Cardiogenic Shock Patients

United States5 participantsStarted 2023-07-06

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
. Age ≥ 18 years-old

Exclusion criteria

. eGFR \< 30 ml/min/1.73 m2
. Severe, non-revascularized coronary artery disease
. Concurrent acute coronary syndrome

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.

Advanced heart failure therapy

Timeframe: 2 years

Inotropes

Timeframe: 2 years

Death

Timeframe: 2 years

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

Timeframe: 2 years

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

Timeframe: 2 years

Trial details

NCT IDNCT05700617

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

David Onsager, MD

7737021000 donsager1@uchgicagomedicine.org

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2
. Age ≥ 18 years-old

Exclusion criteria

. eGFR \< 30 ml/min/1.73 m2
. Severe, non-revascularized coronary artery disease
. Concurrent acute coronary syndrome

What they're measuring

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

Timeframe: 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

Timeframe: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.

Advanced heart failure therapy

Timeframe: 2 years

Inotropes

Timeframe: 2 years

Death

Timeframe: 2 years

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

Timeframe: 2 years

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

Timeframe: 2 years