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Evaluation of unloading the heart in patients with cardiogenic shock treated with mechanical circulatory support devices

HEmodynamic effects of Reducing left ventricular Afterload with impella or intra-aortic balloon CounterpuLsation during veno-arterial Extracorporeal membrane oxygenation in cardiogenic Shock (HERACLES)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82431978
Enrollment
36
Registered
2022-01-19
Start date
2022-03-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiogenic shock Circulatory System Cardiogenic shock

Interventions

HERACLES is a randomised control trial designed to compare the physiological effects on myocardial oxygen supply and demand of ventricular unloading with either an IABP or Impella in patients supporte

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged =18 years with cardiogenic shock of any aetiology 2. On veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support or starting VA-ECMO post PCI 3. Undergoing clinically indicated cardiac catheterisation

Exclusion criteria

Exclusion criteria: 1. Post-cardiotomy cardiogenic shock 2. Confirmed left ventricular thrombus on imaging 3. Age <18 years 4. Pregnancy or peripartum cardiomyopathy 5. Contraindication to either intra-aortic balloon pump (IABP) or percutaneous left ventricular assist device (pLVAD) insertion i.e. =moderate aortic regurgitation (AR), severe peripheral vascular disease (PVD) prohibiting insertion of either device 6. Mechanical aortic valve replacement (AVR)

Design outcomes

Primary

MeasureTime frame
Coronary device flow reserve measured using a coronary guidewire post left ventricular (LV) unloading

Secondary

MeasureTime frame
1. Early effect of LV unloading measured using an LV catheter post LV unloading 2. Minimal microvascular resistance calculated from pressure and flow measurements post LV unloading 3. Time to VA-ECMO decannulation (days) measured using patients' medical records 4. Days alive and off ICU (at 30 days post randomisation) measured using patients' medical records

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026