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

November 8, 2023 updated by: Niguarda Hospital

Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial

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).

Study Overview

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

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early intra-aortic balloon pump (IABP) implantation
IABP implantation within 6 hours since cardiogenic shock symptoms onset
IABP implantation within 6 hours since cardiogenic shock symptoms onset
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60 days
Survival
Time Frame: 60 days
Rate
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
60 days
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)

Through study completion, an avererage of 30 days
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)
Through study completion, an avererage of 30 days
Maximum sequential organ failure assessment (SOFA)
Time Frame: Through study completion, an avererage of 30 days
To compare maximum sequential organ failure assessment (SOFA)
Through study completion, an avererage of 30 days
early IABP vs standard
Time Frame: 60 days
To compare 60-day overall survival among the two groups
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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