HERACLES
Research type
Research Study
Full title
HEmodynamic effects of Reducing lv Afterload with impella or intra-aortic balloon CounterpuLsation during veno-arterial Extracorporeal membrane oxygenation in cardiogenic Shock
IRAS ID
300145
Contact name
Divaka Perera
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN82431978
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Cardiogenic shock occurs when the heart suddenly fails and is unable to meet the body's demands, often leading to death. Cardiogenic shock is becoming more common particularly in patients suffering heart attacks and therefore research into potential treatments to improve the high death rate is urgently needed. Current treatment options are limited and can be associated with an increased death rate.
A promising new treatment is veno-arterial extracorporeal membrane oxygenation (VA-ECMO). This mechanical support system works like heart bypass to support the body whilst the heart recovers. However, while beneficial to most other organs, VA-ECMO can put additional pressure on the heart by pumping bloods backwards into the aorta, preventing it from recovering. If the heart is unable to overcome this increased pressure (or afterload) a number of dangerous events can occur such as the formation of blood clots in the heart or the build up of fluid in the lungs which can be potentially fatal. This problem can be solved by using additional devices in the circulation to “unload” the heart. Two devices are commonly used for this task the intra aortic balloon pump and Impella, but we don’t know which one works better as they have never been directly compared. Additionally, each device has a distinct mechanism of action, the effect of which has never been studied in patients treated with VA-ECMO. Currently therefore hospitals are treating such patients differently due to the lack of available evidence as to the best treatment strategy.
This study will include patients with cardiogenic shock who are being treated with VA-ECMO. They will receive one of the two devices, chosen at random by a computer, and we will study their effect on the patient’s circulation, particularly looking at how the devices change the balance of supply and demand of blood within the heart.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/LO/0853
Date of REC Opinion
13 Jan 2022
REC opinion
Further Information Favourable Opinion