Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    200
  • sponsor
    Niguarda Hospital
Updated on 22 August 2021
hypoperfusion
ejection fraction
heart failure
fluid overload
oliguria
heart transplantation
intraaortic balloon pumping

Summary

The aim of the study is to demonstrate the superiority of early intra-aortic balloon pump implantation at admission over local clinical practice (pharmacological only) in acute decompensated heart failure patients with cardiogenic shock, with respect to 60-day survival or successful bridge to heart replacement therapies (heart transplant or Left Ventricular Assist Device implantation).

Description

Cardiogenic shock (CS) is the most severe form of acute heart failure, with in-hospital mortality up to 50%. Failure to improve mortality has been reported, despite observed improvements in hemodynamics. Previous studies on CS have almost exclusively been focused on CS following an acute coronary syndrome (ACS). Chronic heart failure patients with acute decompensation (ADHF) and CS represent a unique physiologic phenotype compared with ACS patients, which may lead to a differential response to device therapy. Recent evidences emphasize that intra-aortic balloon pump (IABP) is not recommended for patients with ACS-related CS, but it is associated with a high likelihood of bridge to durable Left Ventricular Assist Device or heart transplant without the need for escalation to more potent temporary mechanical circulatory support devices, when implanted in ADHF patients. Data retrieved from the available literature in the setting of patients with CS not related to ACS are poor even in large, well-reported registries.

Accordingly, Altshock-2 trial has been designed to test the superiority of early IABP implantation at admission over local clinical practice (pharmacological only) in ADHF patients with CS, with respect to 60-day survival or successful bridge to heart replacement therapies

Details
Condition Cardiogenic shock
Treatment Early intra-aortic balloon pump (IABP) implantation, Standard of care as vasoactive agent
Clinical Study IdentifierNCT04369573
SponsorNiguarda Hospital
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 and < 75, men and women
) SBP < 90mmHg or MAP < 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload; OR 2) need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg
Reduced ejection fraction (left ventricle systolic function 35%)
Moreover, eligible patients have to fit at least ONE of the following criteria/items of overt hypoperfusion: mixed venous oxygen saturation < 60%; arterial lactates > 2 mmol/L; oliguria < 0.5 ml/Kg/h for at least 6 hours
Eligible patients shouldn't have contraindications to HRT

Exclusion Criteria

Cardiogenic shock symptoms beyond 6 hours
Septic shock with evident septic focus
Cardiogenic shock due to acute myocardial infarction
Cardiogenic shock due to acute myocarditis
Cardiogenic shock due to pulmonary thromboembolism
Reiterating major arrhythmias: VT or VF or AF, with ventricular rate > 160 bpm
Severe aortic valve disease
Obstructive hypertrophic cardiomyopathy or constrictive pericarditis or severe heart failure due to congenital heart disease
Severe peripheral vascular disease that contraindicates mechanical support insertion
Cardiogenic shock secondary to either cardiac or non-cardiac surgery
Comorbidities with ominous prognosis (life expectancy < 1 year)
Estimated glomerular filtration rate severely impaired before enrolment (eGFR<30 ml/min/1.73 m2) or severe COPD or liver cirrhosis
Pregnant, lactating or subjects planning pregnancy during the course of the trial
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