Clinical trial NCT05700617: Cardiac Power Output in Cardiogenic Shock Patients
Official title: Myocardial Reserve in Advanced Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Heart Failure
Cardiogenic Shock
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective, observational, crossover
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg
timeFrame: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.
measure: 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.
measure: Advanced heart failure therapy
timeFrame: 2 years
measure: Inotropes
timeFrame: 2 years
measure: Death
timeFrame: 2 years
measure: Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years
timeFrame: 2 years
measure: Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Durable support
timeFrame: 6 hours
measure: Durable support
timeFrame: 12 hours
measure: Durable support
timeFrame: 24 hours
measure: Durable support
timeFrame: 36 hours
measure: Durable support
timeFrame: 48 hours
measure: Durable support
timeFrame: 72 hours
measure: Hospital discharge
timeFrame: Up to 12 weeks
measure: Home inotropic
timeFrame: 2 years
measure: LVAD decommissioning measuring mmHg
timeFrame: 2 years
measure: LVAD decommissioning measuring L/min/m2
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Valluvan Jeevanandam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.