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Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock (Altshock-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369573
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital

Brief 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).

Condition or disease Intervention/treatment Phase
Cardiogenic Shock Combination Product: Early intra-aortic balloon pump (IABP) implantation Other: Standard of care as vasoactive agent Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre Prospective Controlled Randomized Trial in patients with ADHF complicated by CS. Patients will be randomized 1:1 to early IABP versus standard of care. Early IABP will be defined as IABP implantation for CS patients within 6 hours since CS symptoms onset.
Masking: None (Open Label)
Masking Description: Open
Primary Purpose: Treatment
Official Title: Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
Actual Study Start Date : May 4, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Shock

Arm Intervention/treatment
Active Comparator: Early intra-aortic balloon pump (IABP) implantation
IABP implantation within 6 hours since cardiogenic shock symptoms onset
Combination Product: Early intra-aortic balloon pump (IABP) implantation
IABP implantation within 6 hours since cardiogenic shock symptoms onset

Standard of care as vasoactive agent
Any agent (inotropes and vasopressors) will be allowed. However, the following guide is provided to increase uniformity: 1) vasopressors allowed will be either epinephrine or norepinephrine; 2) as inotropic agent milrinone or dobutamine or levosimendan could be used; 3) dopamine will be allowed in association with milrinone or dobutamine or levosimendan; 4) the maximum inotropic score allowed will be 20
Other: Standard of care as vasoactive agent
Any agent (inotropes and vasopressors) will be allowed. However, the following guide is provided to increase uniformity: 1) vasopressors allowed will be either epinephrine or norepinephrine; 2) as inotropic agent milrinone or dobutamine or levosimendan could be used; 3) dopamine will be allowed in association with milrinone or dobutamine or levosimendan; 4) the maximum inotropic score allowed will be 20.




Primary Outcome Measures :
  1. Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation [ Time Frame: 60 days ]
    Number of participants to heart transplant or Left Ventricular Assist Device implantation

  2. Survival [ Time Frame: 60 days ]
    Rate


Secondary Outcome Measures :
  1. Renal replacement therapy, namely any need of replacement of kidney function due to renal failure by means of the following techniques: continuous hemofiltration and hemodialysis, intermittent hemodialysis, and peritoneal dialysis [ Time Frame: 60 days ]
    Number of participants who need a renal replacement therapy among the two groups (early IABP vs standard)

  2. Maximum inotropic score among the two groups [ Time Frame: Through study completion, an avererage of 30 days ]

    To compare maximum inotropic score among the two groups (early IABP vs standard).

    IS (mcg/kg/min) = [dopamine, dobutamine + 100 x (norepinephrine+epinephrine) +15 x IPDE-3 +10for levosimendan] (Reference: Int J Artif Organs. 2016 Feb;39(2):94-7)


  3. Maximum duration of inotropic/vasopressor therapy among the two groups [ Time Frame: Through study completion, an avererage of 30 days ]
    To compare maximum duration of inotropic/vasopressor therapy among the two groups (early IABP vs standard)

  4. Maximum sequential organ failure assessment (SOFA) [ Time Frame: Through study completion, an avererage of 30 days ]
    To compare maximum sequential organ failure assessment (SOFA)

  5. early IABP vs standard [ Time Frame: 60 days ]
    To compare 60-day overall survival among the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 and < 75, men and women;
  • 1) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369573


Contacts
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Contact: Nuccia Morici, MD +39026444 ext 2308 nuccia.morici@ospedaleniguarda.it
Contact: Federico Pappalardo, MD fedepappa@me.com

Locations
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Italy
ASST GOM Niguarda Recruiting
Milano, Italy, 20125
Contact: Nuccia Morici, MD    +026444 ext 2308    nuccia.morici@ospedaleniguarda.it   
Contact: Federico Pappalardo, MD       fedepappa@me.com   
Sponsors and Collaborators
Niguarda Hospital
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Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT04369573    
Other Study ID Numbers: S_21_08_19_3263
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niguarda Hospital:
Acute decompensated heart failure
cardiogenic shock
intra-aortic balloon pump
Additional relevant MeSH terms:
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Heart Failure
Shock, Cardiogenic
Shock
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases