- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369573
Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock (Altshock-2)
Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock: a Randomized Clinical Trial
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Nuccia Morici, MD
- Phone Number: 2308 +39026444
- Email: nuccia.morici@ospedaleniguarda.it
Study Contact Backup
- Name: Federico Pappalardo, MD
- Email: fedepappa@me.com
Study Locations
-
-
-
Milano, Italy, 20125
- Recruiting
- ASST GOM Niguarda
-
Contact:
- Nuccia Morici, MD
- Phone Number: 2308 +026444
- Email: nuccia.morici@ospedaleniguarda.it
-
Contact:
- Federico Pappalardo, MD
- Email: fedepappa@me.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S_21_08_19_3263
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cardiogenic Shock
-
Odense University HospitalCharite University, Berlin, Germany; Hannover Medical School; Aarhus University... and other collaboratorsActive, not recruitingAcute Myocardial Infarction | Cardiogenic Shock AcuteGermany, Denmark, United Kingdom
-
University Hospital, MontpellierRecruiting
-
Assaf-Harofeh Medical CenterUnknownMyocardial Infarction Complicated With Cardiogenic ShockIsrael
-
Hospices Civils de LyonCompleted
-
Windtree TherapeuticsMomentum Research, Inc.Not yet recruiting
-
Australian and New Zealand Intensive Care Research...Not yet recruitingCardiogenic Shock
-
Yonsei UniversityRecruitingCardiogenic ShockKorea, Republic of
-
Christian SchulzeRecruiting
-
Central Hospital, Nancy, FranceNot yet recruiting
Clinical Trials on Early intra-aortic balloon pump (IABP) implantation
-
Renmin Hospital of Wuhan UniversityNot yet recruiting
-
Lokien van NunenMaquet Cardiovascular; Stichting Toegepaste Wetenschappen (project number 11052)CompletedAcute Myocardial Infarction | Persisting Ischemia | No ReflowNetherlands
-
Indonesia UniversityNational Cardiovascular Center Harapan Kita Hospital IndonesiaCompletedCardiogenic ShockIndonesia
-
Erasmus Medical CenterDutch Heart FoundationRecruitingCardiogenic ShockNetherlands
-
Indonesia UniversityNational Cardiovascular Center Harapan Kita Hospital IndonesiaUnknownPost-Cardiac Arrest SyndromeIndonesia
-
Abiomed Inc.TerminatedCoronary Artery DiseaseUnited States, Netherlands, Canada
-
Abiomed Inc.RecruitingCoronary Artery Disease | Left Ventricular DysfunctionUnited States, Switzerland, Germany, Canada, Italy, Netherlands, United Kingdom
-
Nanjing Medical UniversityRecruitingCoronary Artery Disease | Heart Failure | Acute Coronary Syndrome | Cardiogenic Shock | Left Ventricular Dysfunction | Post-cardiac Surgery | Low Cardiac Output SyndromeChina
-
University of Sao PauloUnknownPostoperative; Dysfunction Following Cardiac SurgeryBrazil
-
British Cardiovascular Intervention SocietyCompletedCoronary Artery Disease | Left Ventricular DysfunctionUnited Kingdom