Cardiac Power Output in Cardiogenic Shock Patients

Официальное название

Myocardial Reserve in Advanced Heart Failure Patients

Обзор

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

Подробное описание

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).

Вмешательства

• Препарат 1:1 Randomization to receive milrinone
  Randomized to receive either inotropic agent: milrinone or no agent

Первичные конечные точки

• Changes in invasive hemodynamics using a pulmonary artery (PA) catheter measuring mmHg [Срок оценки: 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 [Срок оценки: Baseline and 6,12,24,36,72 Hours post-inotrope challenge.]
• Advanced heart failure therapy [Срок оценки: 2 years]
• Inotropes [Срок оценки: 2 years]
• Death [Срок оценки: 2 years]
• Cardiac output measurement using a pulmonary artery (PA) catheter measuring mmHg at 2 years [Срок оценки: 2 years]
• Cardiac output measurement using a pulmonary artery (PA) catheter measuring CO L/min/m2 at 2 years [Срок оценки: 2 years]

Вторичные конечные точки (10)

• Durable support [Срок оценки: 6 hours]
• Durable support [Срок оценки: 12 hours]
• Durable support [Срок оценки: 24 hours]
• Durable support [Срок оценки: 36 hours]
• Durable support [Срок оценки: 48 hours]
• Durable support [Срок оценки: 72 hours]
• Hospital discharge [Срок оценки: Up to 12 weeks]
• Home inotropic [Срок оценки: 2 years]
• LVAD decommissioning measuring mmHg [Срок оценки: 2 years]
• LVAD decommissioning measuring L/min/m2 [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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
• Intent for admission based on RHC data

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Chicago — Chicago

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 15261929

Идентификаторы

NCT: NCT05700617 · IRB22-0817

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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