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

Primary Purpose

Cardiogenic Shock

Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Early intra-aortic balloon pump (IABP) implantation
Standard of care as vasoactive agent
Sponsored by
Niguarda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock focused on measuring Acute decompensated heart failure, cardiogenic shock, intra-aortic balloon pump

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • Age ≥ 18 and < 75, men and women;
  • need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg.
  • Left ventricle systolic function ≤35%
  • SCAI B-D according to CSWG definition (JACC 2022)

EXCLUSION CRITERIA

  • septic shock with evident septic focus;
  • severe peripheral vascular disease
  • CS secondary to cardiac and non-cardiac surgery;
  • Acute myocardial infarction within 1 month;
  • Suspected or documented myocarditis
  • Pulmonary embolism
  • Chronic end-stage organ dysfunction that would preclude heart transplant/durable VAD
  • ominous prognosis (life expectancy < 1 year);
  • any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
  • pregnant, lactating or women planning pregnancy during the course of the trial.

Sites / Locations

  • ASST GOM NiguardaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Early intra-aortic balloon pump (IABP) implantation

Standard of care as vasoactive agent

Arm Description

IABP implantation within 6 hours since cardiogenic shock symptoms onset

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

Outcomes

Primary Outcome Measures

Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation
Number of participants to heart transplant or Left Ventricular Assist Device implantation
Survival
Rate

Secondary Outcome Measures

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
Number of participants who need a renal replacement therapy among the two groups (early IABP vs standard)
Maximum inotropic score among the two groups
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)
Maximum duration of inotropic/vasopressor therapy among the two groups
To compare maximum duration of inotropic/vasopressor therapy among the two groups (early IABP vs standard)
Maximum sequential organ failure assessment (SOFA)
To compare maximum sequential organ failure assessment (SOFA)
early IABP vs standard
To compare 60-day overall survival among the two groups

Full Information

First Posted
April 23, 2020
Last Updated
January 10, 2023
Sponsor
Niguarda Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04369573
Brief Title
Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
Acronym
Altshock-2
Official Title
Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2020 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Niguarda Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
Acute decompensated heart failure, cardiogenic shock, intra-aortic balloon pump

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early intra-aortic balloon pump (IABP) implantation
Arm Type
Active Comparator
Arm Description
IABP implantation within 6 hours since cardiogenic shock symptoms onset
Arm Title
Standard of care as vasoactive agent
Arm Type
Other
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
Early intra-aortic balloon pump (IABP) implantation
Intervention Description
IABP implantation within 6 hours since cardiogenic shock symptoms onset
Intervention Type
Other
Intervention Name(s)
Standard of care as vasoactive agent
Intervention Description
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 Measure Information:
Title
Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation
Description
Number of participants to heart transplant or Left Ventricular Assist Device implantation
Time Frame
60 days
Title
Survival
Description
Rate
Time Frame
60 days
Secondary Outcome Measure Information:
Title
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
Description
Number of participants who need a renal replacement therapy among the two groups (early IABP vs standard)
Time Frame
60 days
Title
Maximum inotropic score among the two groups
Description
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)
Time Frame
Through study completion, an avererage of 30 days
Title
Maximum duration of inotropic/vasopressor therapy among the two groups
Description
To compare maximum duration of inotropic/vasopressor therapy among the two groups (early IABP vs standard)
Time Frame
Through study completion, an avererage of 30 days
Title
Maximum sequential organ failure assessment (SOFA)
Description
To compare maximum sequential organ failure assessment (SOFA)
Time Frame
Through study completion, an avererage of 30 days
Title
early IABP vs standard
Description
To compare 60-day overall survival among the two groups
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Age ≥ 18 and < 75, men and women; need of vasoactive agents to maintain SBP > 90 mmHg or MAP > 60 mmHg. Left ventricle systolic function ≤35% SCAI B-D according to CSWG definition (JACC 2022) EXCLUSION CRITERIA septic shock with evident septic focus; severe peripheral vascular disease CS secondary to cardiac and non-cardiac surgery; Acute myocardial infarction within 1 month; Suspected or documented myocarditis Pulmonary embolism Chronic end-stage organ dysfunction that would preclude heart transplant/durable VAD ominous prognosis (life expectancy < 1 year); any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial pregnant, lactating or women planning pregnancy during the course of the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuccia Morici, MD
Phone
+39026444
Ext
2308
Email
nuccia.morici@ospedaleniguarda.it
First Name & Middle Initial & Last Name or Official Title & Degree
Federico Pappalardo, MD
Email
fedepappa@me.com
Facility Information:
Facility Name
ASST GOM Niguarda
City
Milano
ZIP/Postal Code
20125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuccia Morici, MD
Phone
+026444
Ext
2308
Email
nuccia.morici@ospedaleniguarda.it
First Name & Middle Initial & Last Name & Degree
Federico Pappalardo, MD
Email
fedepappa@me.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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