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NCT04369573: Altshock-2
Study on Early Intra-aortic Balloon Pump Placement in Acute Decompensated Heart Failure Complicated by Cardiogenic Shock
Phase 4 trial testing Early intra-aortic balloon pump (IABP) implantation in Cardiogenic Shock in 100 participants. Terminated before completion.
14 October 2024
Quick facts
| Lead sponsor | Niguarda Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 4 May 2020 |
| Primary completion | 14 October 2024 |
| Estimated completion | 14 October 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Early intra-aortic balloon pump (IABP) implantation
- Standard of care as vasoactive agent
Conditions studied
- Cardiogenic Shock — all drugs for Cardiogenic Shock →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04369573
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiogenic Shock
Currently open trials in the same condition.
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07345559 — Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock · NA · recruiting
- NCT07374289 — On Scene ECPR in Ostrava · NA · recruiting
- NCT07402018 — Intra-aortic Balloon Counterpulsation (IABC) Compliance · recruiting
- NCT07309029 — Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR · recruiting
Other Niguarda Hospital trials
Trials by the same sponsor.
- NCT05105399 — Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures · NA · not yet recruiting
- NCT07153224 — The MICROSCOPE Project · not yet recruiting
- NCT04763993 — Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study · NA · not yet recruiting
- NCT07432347 — Decoding Epigenetic Mechanisms Driving Immune Evasion in Liver Cancer With Omics Approaches · recruiting
- NCT07234409 — Clinical Trial Addressing the Best Surgical Approach for Partial Nephrectomy With Single Port Robotic System in the Mana · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04369573 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Niguarda Hospital
- Last refreshed: 23 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04369573.
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