Unloading in Heart Failure Cardiogenic Shock

N/ANot Yet RecruitingNCT05064202

Amsterdam UMC, location VUmc456 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

456

Conditions

Cardiogenic Shock

Interventions

Impella 5.5DEVICE

temporary Mechanical Circulatory Support (tMCS)

InotropesDRUG

Enoximone, Dobutamine, Dopamine, Milrinone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 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: 1. Hypotension 1. systolic blood pressure \<90 mmHg for at least 30 min OR 2. mean arterial pressure \<60 mmHg for at least 30 min 2. Hypoperfusion 1. 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) 2. 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) 3. creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L) 4. oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h) 3. Inotropes/vasoactives (use of) Exclusion Criteria: 1. Contraindications for Impella 5.5 2. Severe concomitant RV failure 3. Grade IV mitral regurgitation eligible for surgical treatment 4. Dialysis for end-stage renal failure 5. Acute coronary syndrome (type 1, AMI) 6. Bradycardia and AV blocks necessitating pacemaker implantation 7. HD parameters and biochemistry alterations as specifically defined for SCAI CS E 8. Combined cardiorespiratory failure 9. Resuscitated (OHCA/PEA) 10. History of CVA or TIA within previous 90 days 11. History of acute myocardial infarction within previous 30 days 12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions 13. Inflammatory 14. Active systemic infections 15. Acute myocarditis

Locations (5)

Academical Medical Center (AMC)

Amsterdam, Netherlands

VU University Medical Center (VUMC)

Amsterdam, Netherlands

Univerity Medical Center Groningen (UMCG)

Groningen, Netherlands

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Outcomes

Primary Outcomes

Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)

Number of patients suffering from any of: all-cause death, renal replacement therapy and rehospitalization or urgent hospital visit for heart failure up to 90 days

Time frame: baseline to 90 days

Secondary Outcomes

In-hospital mortality (Efficacy - Secondary Endpoint)

Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation

Time frame: baseline to 28 days

In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)

Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization)

Time frame: baseline to 28 days

Cardiac mortality (Efficacy - Secondary Endpoint)

Number of patients that died of any cause at 90 days and 1 year

Time frame: baseline to 1 year

All-cause mortality (Efficacy - Secondary Endpoint)

Number of patients that died of any cause at 90 days and 1 year

Time frame: baseline to 1 year

Mechanical ventillation (Efficacy - Secondary Endpoint)

Number of patients that were mechanically ventilated during hospitalization, up to day 90 and 1 year

Time frame: baseline to 1 year

Renal replacement therapy (Efficacy - Secondary Endpoint)

Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year

Central Contacts

Alexander Nap, MD PhD

CONTACT

+31(0)614102081 a.nap@amsterdamumc.nl

Data from ClinicalTrials.gov

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