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NCT04369573: Altshock-2

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

Terminated Phase 4 Last updated 23 October 2024
What this trial tests

Phase 4 trial testing Early intra-aortic balloon pump (IABP) implantation in Cardiogenic Shock in 100 participants. Terminated before completion.

Timeline
4 May 2020
Primary endpoint
14 October 2024
14 October 2024

Quick facts

Lead sponsorNiguarda Hospital
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment100
Start date4 May 2020
Primary completion14 October 2024
Estimated completion14 October 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Niguarda Hospital

Who can join

Adults 18 to 75, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Contemporary approach to cardiogenic shock care: a state-of-the-art review.
    Mehta A, Vavilin I, Nguyen AH, Batchelor WB, et al · · 2024 · cited 27× · PMID 38545346 · DOI 10.3389/fcvm.2024.1354158
  2. Research Priorities in Critical Care Cardiology: JACC Expert Panel.
    Miller PE, Huber K, Bohula EA, Krychtiuk KA, et al · · 2023 · cited 24× · PMID 38057075 · DOI 10.1016/j.jacc.2023.09.828
  3. Early Intra-Aortic Balloon Support for Heart Failure-Related Cardiogenic Shock: A Randomized Clinical Trial.
    Morici N, Sacco A, Frea S, Rota M, et al · · 2025 · cited 19× · PMID 40162941 · DOI 10.1016/j.jacc.2025.03.003
  4. Advanced heart failure: from definitions to therapeutic options.
    Garascia A, Palazzini M, Tedeschi A, Sacco A, et al · · 2023 · cited 14× · PMID 37125285 · DOI 10.1093/eurheartjsupp/suad028
  5. Left Ventricular Mechanical Circulatory Support Devices for Cardiogenic Shock After Myocardial Infarction.
    Giao DM, Giugliano RP. · · 2025 · cited 2× · PMID 40343681 · DOI 10.1007/s40119-025-00413-9
  6. The management of heart failure cardiogenic shock: an international RAND appropriateness panel.
    Williams S, Kalakoutas A, Olusanya S, Schrage B, et al · · 2024 · cited 2× · PMID 38566212 · DOI 10.1186/s13054-024-04884-5
  7. Glimpse into the future.
    Moller JE, Mangner N, Pappalardo F, Thiele H. · · 2023 · cited 1× · PMID 38093769 · DOI 10.1093/eurheartjsupp/suad133

Verify or expand the search:

Other recruiting trials for Cardiogenic Shock

Currently open trials in the same condition.

Other Niguarda Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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