Unloading in Heart Failure Cardiogenic Shock

Официальное название

Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.

Обзор

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

Подробное описание

To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care

Вмешательства

• Устройство Impella 5.5
  temporary Mechanical Circulatory Support (tMCS)
• Препарат Inotropes
  Enoximone, Dobutamine, Dopamine, Milrinone

Первичные конечные точки

• Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint) [Срок оценки: baseline to 90 days]

Вторичные конечные точки (12)

• In-hospital mortality (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 28 days]
• In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 28 days]
• Cardiac mortality (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• All-cause mortality (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• Mechanical ventillation (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• Renal replacement therapy (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• Hospitalization time (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 28 days]
• Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 28 days]
• LVAD / Heart transplantation (Efficacy - Secondary Endpoint) [Срок оценки: baseline to 1 year]
• KCCQ-12 (Efficacy - Secondary Endpoint) [Срок оценки: 90 days, 1 year]

Критерии участия

Критерии включения

1\. Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%) 2. Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion) 3. Evidence of CS with presence of at least 2 of the 3 following:

• Hypotension

• systolic blood pressure <90 mmHg for at least 30 min OR
• mean arterial pressure <60 mmHg for at least 30 min
• Hypoperfusion

• lactate > 2.0 mmol/L (two consecutive values > 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors)
• amino-L-transferase >200 U/L (two consecutive values > 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors)
• creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L)
• oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
• Inotropes/vasoactives (use of)

Критерии исключения

• Contraindications for Impella 5.5
• Severe concomitant RV failure
• Grade IV mitral regurgitation eligible for surgical treatment
• Dialysis for end-stage renal failure
• Acute coronary syndrome (type 1, AMI)
• Bradycardia and AV blocks necessitating pacemaker implantation
• HD parameters and biochemistry alterations as specifically defined for SCAI CS E
• Combined cardiorespiratory failure
• Resuscitated (OHCA/PEA)
• History of CVA or TIA within previous 90 days
• History of acute myocardial infarction within previous 30 days
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
• Inflammatory
• Active systemic infections
• Acute myocarditis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 5 центров

• Academical Medical Center (AMC) — Amsterdam
• VU University Medical Center (VUMC) — Amsterdam
• Univerity Medical Center Groningen (UMCG) — Groningen
• Leids Universitair Medisch Centrum (LUMC) — Leiden
• University Medical Center Utrecht (UMCU) — Utrecht

Идентификаторы

NCT: NCT05064202 · NL84199.018.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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