Cardiogenic ShockPhase 4Altshock-2NCT04369573
Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
A Phase 4 study testing Early intra-aortic balloon pump (IABP) implantation in people with Cardiogenic Shock, run by Niguarda Hospital at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Early intra-aortic balloon pump (IABP) implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2020to 14 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Cardiogenic Shock
- Being tested
- Early intra-aortic balloon pump (IABP) implantation, Standard of care as vasoactive agent
- Keywords
- Acute decompensated heart failure, cardiogenic shock, intra-aortic balloon pump
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intra-aortic balloon pump (IABP) implantationCombination product
IABP implantation within 6 hours since cardiogenic shock symptoms onset
Standard of care as vasoactive agentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early intra-aortic balloon pump (IABP) implantation | Active comparator | IABP implantation within 6 hours since cardiogenic shock symptoms onset Receives: Combination Product: Early intra-aortic balloon pump (IABP) implantation |
| Standard of care as vasoactive agent | Other | 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 Receives: Other: Standard of care as vasoactive agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Survival
Rate
Measured: 60 days
Secondary outcomes (5)
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)
Measured: 60 days
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)
Measured: Through study completion, an avererage of 30 days
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)
Measured: Through study completion, an avererage of 30 days
Maximum sequential organ failure assessment (SOFA)
To compare maximum sequential organ failure assessment (SOFA)
Measured: Through study completion, an avererage of 30 days
early IABP vs standard
To compare 60-day overall survival among the two groups
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start4 May 2020
- Primary completion14 Oct 2024
- Study completion14 Oct 2024
Why it stopped: Because the Data Safety Monitoring Board after the interim analisys concluded that the experimental treatment is not proviiding any minimal full benefit compared to the contrtol. They then reccomended to stop the trial due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369573
- Sponsor's protocol ID
- S_21_08_19_3263
- Acronym
- Altshock-2
- Status last verified
- Oct 2024
- First submitted
- 23 Apr 2020
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Morici N, Sacco A, Frea S, Rota M, Villanova L, Gravinese C, Dini CS, D'Ettore N, Maj G, De Lio G, Potena L, Valente S, Sabatino M, Viola G, Garatti L, Tavecchia GA, Bertoldi L, Oliva F, Kapur NK, Tavazzi G, De Ferrari GM, Pappalardo F; Altshock-2 Investigators. Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial. J Am Coll Cardiol. 2025 Apr 29;85(16):1587-1597. doi: 10.1016/j.jacc.2025.03.003. Epub 2025 Mar 30.
PubMed 40162941
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04369573
- Acronym / sponsor ID
- Altshock-2 / S_21_08_19_3263
- Conditions
- Cardiogenic Shock
- Keywords
- Acute decompensated heart failure, cardiogenic shock, intra-aortic balloon pump
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the Data Safety Monitoring Board after the interim analisys concluded that the experimental treatment is not proviiding any minimal full benefit compared to the contrtol. They then reccomended to stop the trial due to futility
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 4 May 2020 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 14 Oct 2024 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early intra-aortic balloon pump (IABP) implantation | Active comparator | Combination Product: Early intra-aortic balloon pump (IABP) implantationIABP implantation within 6 hours since cardiogenic shock symptoms onset |
| Standard of care as vasoactive agent | Other | Other: Standard of care as vasoactive agentAny 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early intra-aortic balloon pump (IABP) implantationIABP implantation within 6 hours since cardiogenic shock symptoms onset | Combination product | Early intra-aortic balloon pump (IABP) implantation |
| Standard of care as vasoactive agentAny 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 |
Primary outcome
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
Survival
Time frame: 60 days
Rate
5 secondary outcomes
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
Maximum inotropic score among the two groups
Time frame: 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
Maximum sequential organ failure assessment (SOFA)
Time frame: Through study completion, an avererage of 30 days
early IABP vs standard
Time frame: 60 days
Results and safety
The study was stopped early (reason given: Because the Data Safety Monitoring Board after the interim analisys concluded that the experimental treatment is not proviiding any minimal full benefit compared to the contrtol. They then reccomended to stop the trial due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Derived from this study: PubMed 40162941Morici N, Sacco A, Frea S, Rota M, Villanova L, Gravinese C, Dini CS, D'Ettore N, Maj G, De Lio G, Potena L, Valente S, Sabatino M, Viola G, Garatti L, Tavecchia GA, Bertoldi L, Oliva F, Kapur NK, Tavazzi G, De Ferrari GM, Pappalardo F; Altshock-2 Investigators. Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial. J Am Coll Cardiol. 2025 Apr 29;85(16):1587-1597. doi: 10.1016/j.jacc.2025.03.003. Epub 2025 Mar 30.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early intra-aortic balloon pump (IABP) implantation in people with Cardiogenic Shock, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Because the Data Safety Monitoring Board after the interim analisys concluded that the experimental treatment is not proviiding any minimal full benefit compared to the contrtol. They then reccomended to stop the trial due to futility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful bridge to heart replacement therapies, namely heart transplantation or left ventricular assist device implantation (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.